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Mammography Equipment Evaluation (MEE) Scope for Newly Installed FFDM Systems

PDF Printer Version

August 29, 2008

General

According to the final regulations’ Section 900.12(e)(10):
“Additional evaluations of mammography units or image processors shall be conducted whenever a new unit or processor is installed, a unit or processor is disassembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.”

When applying this regulation to a newly installed x-ray unit, it means that the new unit must be evaluated by a medical physicist (or someone under their direct supervision) before clinical use.

For a new FFDM system, the “applicable” tests in paragraph (b) are, for the most part, parallel to those in screen-film systems. However, the “applicable” tests in paragraph (e) depend on the specific FFDM system in question, and specifically on what is stated in the system’s QC manual. Because of this variation, we asked all the current FFDM manufactures to provide us with what they view as the “applicable” MEE tests for a newly installed FFDM system. The following sections list the required tests for each FFDM system, as provided to the FDA by each FFDM manufacturer. Please use the appropriate list in this document as a reference for your MEE testing of a newly installed FFDM system.

A. GE – All Units

MAMMOGRAPHY EQUIPMENT EVALUATION OF A NEW GE FFDM SYSTEM
Applicable tests and checks the medical physicist must perform as part of the MEE

Introduction

The following two worksheets list tests and checks that are considered to be applicable to the installation of a new FFDM system including acquisition system, display workstation, and printer.

The worksheet "MQSA Reqts" lists the applicable tests and checks from the Quality Mammography Standards in 21 CFR 900.12(b) Equipment.

The worksheet "System QC Reqts" lists the applicable tests from the QC manuals for the FFDM system components. Please note that the names of the tests or the tests themselves may change as the QC plans evolve with the systems. However, the manuals include a section entitled "Summary of Mammography Equipment Evaluation of …" at the conclusion of Chapter 3 Guidance. This section will include the list of tests considered applicable for the system for which the manual was written.

MAMMOGRAPHY EQUIPMENT EVALUATION OF A NEW GE FFDM SYSTEM
Applicable tests and checks the medical physicist must perform as part of the MEE

Tests and checks based on 21 CFR 900.12(b) Equipment

MQSA Quality Std. Requirement Comment
(2) General All radiographic equipment used for mammography shall be specifically designed for mammography and shall be certified pursuant to Sec. 1010.2 of this chapter as meeting the applicable requirements of Secs. 1020.30 and 1020.31 of this chapter in effect at the date of manufacture.  
(3) Motion of tube-image receptor assembly (i) The assembly shall be capable of being fixed in any position where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.  
(ii) The mechanism ensuring compliance with paragraph (b)(3)(i) of this section shall not fail in the event of power interruption.  
(4) Image receptor sizes (iii) Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.  
(5) Light fields For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 ft-candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.  
(6) Magnification (i) Systems used to perform non interventional problem-solving procedures shall have radiographic magnification capability available for use by the operator.  
(ii) Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.  
(7) Focal spot selection (i) When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.  
(ii) When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.  
(iii) When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.  
(8) Compression All mammography systems shall incorporate a compression device.  
(i) Application of compression. Effective October 28, 2002, each system shall provide:  
(A) An initial power-driven compression activated by hands-free controls operable from both sides of the patient; and  
(B) Fine adjustment compression controls operable from both sides of the patient.  
(ii) Compression paddle.  
(A) Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system. Compression paddles for special purposes, including those smaller than the full size of the image receptor (for "spot compression") may be provided. Such compression paddles for special purposes are not subject to the requirements of paragraphs (b)(8)(ii)(D) and (b)(8)(ii)(E) of this section.  
(B) Except as provided in paragraph (b)(8)(ii)(C) of this section, the compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.  
(C) Equipment intended by the manufacturer's design to not be flat and parallel to the breast support table during compression shall meet the manufacturer's design specifications and maintenance requirements. The manufacturer's specifications and maintenance requirements can generally be found in the FFDM acquisition system Operator Manual in the Maintenance chapter.
(D) The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.  
(E) The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.  
(9) Technique factor selection and display (i) Manual selection of milliampere seconds (mAs) or at least one of its component parts (milliampere (mA) and/or time) shall be available.  
(ii) The technique factors (peak tube potential in kilovolt (kV) and either tube current in mA and exposure time in seconds or the product of tube current and exposure time in mAs) to be used during an exposure shall be indicated before the exposure begins, except when automatic exposure controls (AEC) are used, in which case the technique factors that are set prior to the exposure shall be indicated.  
(iii) Following AEC mode use, the system shall indicate the actual kilovoltage peak (kVp) and mAs used during the exposure. The mAs may be displayed as mA and time.  
(13) Film processing solutions For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer. This would be applicable to a facility that uses a hardcopy printer with wet development processing. Refer to the printer manufacturer's documentation for specifications.
(14) Lighting The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians. This would be applicable to a facility that uses hardcopy image review and for comparison to prior images acquired using screen-film systems.
(15) Film masking devices Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility. This would be applicable to a facility that uses hardcopy image review and for comparison to prior images acquired using screen-film systems.

MAMMOGRAPHY EQUIPMENT EVALUATION OF A NEW GE FFDM SYSTEM

Applicable tests and checks the medical physicist must perform as part of the MEE

Tests and checks based on acquisition system QC manuals

Note: The tests listed here are representative of those recommended for testing a new GE Senographe FFDM acquisition system. However, they are subject to change as QC manuals evolve. The medical physicist is referred to the Guidance chapter in the current QC manual of the equipment being evaluated for the latest recommendations. The Guidance chapter concludes with a "Summary of Mammography Equipment Evaluation for …" which lists the tests recommended for the MEE of the system.

Test Test Location Comment
Flat Field and Image Quality Checks Chapter 1: QC Tests for the Radiologic Technologist  
CNR and MTF Measurement Chapter 1: QC Tests for the Radiological Technologist The physicist may substitute the "Sub-System MTF Measurement" for the two tests "CNR and MTF Measurement" and "Evaluation of Focal Spot Performance."
AOP Mode and SNR Check Chapter 1: QC Tests for the Radiological Technologist  
Compression Force Test Chapter 1: QC Tests for the Radiological Technologist  
Collimation Assessment Chapter 2: QC Tests for the Medical Physicist  
Evaluation of Focal Spot Performance Chapter 2: QC Tests for the Medical Physicist The physicist may substitute the "Sub-System MTF Measurement" for the two tests "CNR and MTF Measurement" and "Evaluation of Focal Spot Performance."
Sub-system MTF Chapter 2: QC Tests for the Medical Physicist The physicist may substitute the "Sub-System MTF Measurement" for the two tests "CNR and MTF Measurement" and "Evaluation of Focal Spot Performance."
Breast Entrance Exposure, Average Glandular Dose, and Reproducibility Chapter 2: QC Tests for the Medical Physicist  
Artifact Evaluation and Flat Field Uniformity Chapter 2: QC Tests for the Medical Physicist  
kVp Accuracy and Reproducibility Chapter 2: QC Tests for the Medical Physicist  
Beam Quality Assessment (Half-Value Layer Measurement) Chapter 2: QC Tests for the Medical Physicist  
Radiation Output Chapter 2: QC Tests for the Medical Physicist  
Mammographic Unit Evaluation Chapter 2: QC Tests for the Medical Physicist  

Tests and checks based on display system QC manuals

Note: The tests listed here are representative of those recommended for testing a new GE Senographe FFDM display system. However, they are subject to change as QC manuals evolve. The medical physicist is referred to the Guidance chapter in the current QC manual of the equipment being evaluated for the latest recommendations. The Guidance chapter concludes with a "Summary of Mammography Equipment Evaluation for …" which lists the tests recommended for the MEE of the system.

Test Test Location Comment
Viewing Conditions Check and Setting Chapter 2: QC Tests for the Medical Physicist  
Monitor Calibration Chapter 2: QC Tests for the Medical Physicist The Medical Physicist must ensure that baseline luminance measurements for each monitor have been provided by the Field Service Engineer.
Image Quality - SMPTE Pattern Chapter 2: QC Tests for the Medical Physicist  
Analysis of the Seno Advantage Screen Uniformity Chapter 2: QC Tests for the Medical Physicist  

Tests and checks based on printer system QC manuals

Note: Follow the recommendations provided by the manufacturer of the printer.

B. Fischer SenoScan – Currently serviced by CareStream Health, Inc.

It is the responsibility of the medical physicist to carry out the Fischer SenoScan FFDM System MEE after the equipment is first installed and before clinical use commences, as stated in CFR 900.12(e)(10). This MEE must include all QC tests listed under both Quality Control Activities for the Medical Physicist and Quality Control Activities for the Radiologic Technologist in accordance with 900.12(b) and 900.12(e) where applicable.

For the installation of a new SenoScan system, the applicable tests in Section 900.12(b) are listed in Table 6 in the ACR Q.C. Manual (1999), with the exception of 11, 12, and 13. The applicable tests in Section 900.12(e) are listed in the table below.

1. Medical physicist Tests
X-ray Field Size
Image to X-ray Field Size
Chest Wall Missed Tissue
Light Field
Compression Paddle Alignment
kVp Accuracy Test
Linearity, Reproducibility & Accuracy
Half Value Layer & Output
Dosimetry – Average Glandular Dose
Phantom Image Acquisition
Image Quality
System Resolution and Scan Speed Uniformity
Flat Field Test
Geometric Distortion & Resolution Uniformity
Automatic Decompression Control
System Artifacts
Daily Image Display Monitor(s) Check
Image Viewing Room Illuminance
2. Applicable Radiologic Technologist QC Tests
Laser Imager Quality Test (if applicable)
Image Display Test for Barco MGD521 Monitors (CRT)
Image Display Test for Planar C5i Monitors (Flat Panel)
Phantom Image Acquisition Test
Phantom Image Quality Test
Detector Cal and Flat Field
System Resolution & Scan Speed Uniformity
System Operation
Reject/Repeat Analysis
Compression Force

C. Selenia Full Field Digital Mammography System MEE

It is the responsibility of the medical physicist to carry out the LORAD Selenia FFDM System Equipment Evaluation before clinical use commences after the equipment is first installed or significantly modified-See CFR 900.12(e)(10). The LORAD Selenia Equipment Evaluation must include all QC tests listed under both Quality Control Activities for the Medical Physicist and Quality Control Activities for the Radiologic Technologist in accordance to 900.12(b) and 900.12(e) where applicable. For the installation of a new Selenia system, the applicable tests in Section 900.12(b) are listed in Table 6 in the ACR Q.C. Manual (1999), with the exception of 11, 12, and 13. The applicable tests in Section 900.12(e) are listed in the table below.

The medical physicist must also provide operating levels and control limits to the technologist for the QC tests pertained to the technologist, where appropriate, e.g., SNR and CNR tests. Such operating levels and control limits must follow the guidelines of the LORAD Selenia FFDM system QC Manual.

QC Tests To Be Performed by the Medical Physicist
Upon Installation (MEE) (Ref. Selenia Q.C. Manual)
Mammographic Unit Assembly Evaluation
Collimation Assessment
Artifact Evaluation
kVp Accuracy & Reproducibility
Beam Quality Assessment – HVL
Evaluation of System Resolution
AEC Function Performance
Breast Entrance Exposure, AEC Reproducibility and Average Glandular Dose
Radiation Output Rate
Phantom Image Quality Evaluation
Signal to Noise and Contrast to Noise
Detector Ghosting (Optional)
View Box & Room Illuminance
Diagnostic Review Workstation QC
DICOM Printer QC
Detector Flat Field Calibration
Compression Thickness Indicator
Compression
If a wet film processor is used, the following tests are
also required (Ref. ACR Mammography Quality Control Manual):
Dark Room Cleanliness
Processor Quality Control
Analysis of Fixer Retention in Film
Dark Room Fog

D. Siemens Mammomat NovationDR

Mammomat NovationDR Full Field Digital Mammography System QC Plan
1748-1 Effective Date: 04/21/2008. (for questions:1-888-826-9702)

Physicist requirements for MEE testing (new unit)

The medical physicist, at a minimum, must assure compliance with the following:

  1. MQSA Requirements for Mammography Equipment Checklist - Code of Federal Regulations Section 900.12(b):

Feature

FDA Rule
Section

Requirement

Applies
to

Meets FDA Requirements?
(if NA, please explain)
Motion of tube-image
receptor assembly

3(i)

The assembly shall be capable of being fixed in any position
where it is designed to operate. Once fixed in any such position, it shall not undergo unintended motion.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

3(ii)

This mechanism shall not fail in the event of power interruption.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Image receptor sizes

4(i)

Systems using screen-film image receptors shall provide, at a minimum, for operation with image receptors of 18 x 24 cm and 24 x 30 cm.

S-F

[ ]Yes [ ]No [ ]N/A

4(ii)

Systems using screen-film image receptors shall be equipped
with moving grids matched to all image receptor sizes provided.

S-F

[ ]Yes [ ]No [ ]N/A

4(iii)

Systems used for magnification procedures shall be capable of operation with the grid removed from between the source and image receptor.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Beam limitation and
light fields

5(i)

All systems shall have beam limiting devices that allow the
useful beam to extend to or beyond the chest wall edge of the
image receptor.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

5(ii)

For any mammography system with a light beam that passes through the X-ray beam-limiting device, the light shall provide an average illumination of not less than 160 lux (15 ft-candles) at 100 cm or the maximum source-image receptor distance (SID), whichever is less.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Magnification

6(i)

Systems used to perform non-interventional problem-solving
procedures shall have radiographic magnification capability
available for use by the operator.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

6(ii)

Systems used for magnification procedures shall provide, at a minimum, at least one magnification value within the range of 1.4 to 2.0.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Focal spot selection

7(i)

When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

7(ii)

When more than one target material is provided, the system shall indicate, prior to exposure, the pre-selected target material.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

7(iii)

When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Application of compression

8(i)(A)

Each system shall provide an initial power-driven compression activated by hands-free controls operable from both sides of the patient.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

8(i)(B)

Each system shall provide fine adjustment compression controls operable from both sides of the patient.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Compression paddle

8(ii)(A)

Systems shall be equipped with different sized compression paddles that match the sizes of all full-field image receptors provided for the system.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

8(ii)(B)

The compression paddle shall be flat and parallel to the breast support table and shall not deflect from parallel by more than 1.0 cm at any point on the surface of the compression paddle when compression is applied.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

8(ii)(C)

Equipment intended by the manufacturer’s design to not be flat and parallel to the breast support table during compression shall meet the manufacturer’s design specifications and maintenance requirements.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

8(ii)(D)

The chest wall edge of the compression paddle shall be straight and parallel to the edge of the image receptor.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

8(ii)(E)

The chest wall edge may be bent upward to allow for patient comfort but shall not appear on the image.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Technique factor selection and display

9(i)

Manual selection of mAs or at least one of its component parts (mA and/or time) shall be available.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

9(ii)

The technique factors (kVp and either mA and seconds or mAs) to be used during an exposure shall be indicated before the exposure begins, except when AEC is used, in which case the technique factors that are set prior to the exposure shall be indicated.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A

9(iii)

Following AEC mode use, the system shall indicate the actual kVp and mAs (or mA and time) used during the exposure.

S-F &
FFDM

[ ]Yes [ ]No [ ]N/A
Automatic exposure control

10(i)

Each screen-film system shall provide an AEC mode that is operable in all combinations of equipment configuration provided, e.g., grid, non-grid; magnification, non-magnification; and various target-filter combinations.

S-F

[ ]Yes [ ]No [ ]N/A

10(ii)

The positioning or selection of the detector shall permit flexibility in the placement of the detector under the target tissue. The size and the available positions of the detector shall be clearly indicated at the X-ray input surface of the breast compression paddle. The selected position of the detector shall be clearly indicated.

S-F

[ ]Yes [ ]No [ ]N/A

10(iii)

The system shall provide means for the operator to vary the selected optical density from the normal (zero) setting.

S-F

[ ]Yes [ ]No [ ]N/A
X-ray film*

11

The facility shall use X-ray film for mammography that has been designated by the film manufacturer as appropriate for mammography.

S-F

[ ]Yes [ ]No [ ]N/A
Intensifying screens*

12

The facility shall use intensifying screens for mammography that have been designated by the screen manufacturer as appropriate for mammography and shall use film that is matched to the screen’s spectral output as specified by the manufacturer.

S-F

[ ]Yes [ ]No [ ]N/A
Film processing solutions*

13

For processing mammography films, the facility shall use chemical solutions that are capable of developing the films used by the facility in a manner equivalent to the minimum requirements specified by the film manufacturer.

S-F

[ ]Yes [ ]No [ ]N/A
Lighting*

14

The facility shall make special lights for film illumination, i.e., hot-lights, capable of producing light levels greater than that provided by the view box, available to the interpreting physicians.

S-F &
FFDM (for hardcopy comparison)

[ ]Yes [ ]No [ ]N/A
Film masking devices*

15

Facilities shall ensure that film masking devices that can limit the illuminated area to a region equal to or smaller than the exposed portion of the film are available to all interpreting physicians interpreting for the facility.

S-F &
FFDM (for hardcopy comparison)

[ ]Yes [ ]No [ ]N/A

* N/A is acceptable for new units at existing facilities if these were previously evaluated and have not changed

  1. Image Acquisition System: Perform all tests* in Section 1.9 of the Siemens Mammomat NovationDR QC Manual Version 5, with the exception of the audit of Technologist QC program (Reference section 1.1). Ghost image test is optional but recommended. All of the Technologist tests are captured in the medical physicist (MP) testing, except for the semi-annual compression force test (Reference section 3.6), which then must be performed by the MP in addition to the Section 1.9 tests.
*Section 1.9 Recommended Frequency of QC Tests – Medical Physicist
All of the below tests are to be performed at the MEE and Annually – except where noted.
QC Manual Section Test to be performed by MP for the Image Acquisition System
4.2 Mechanical Checks
4.3 Acquisition Workstation Monitor Check
5.1 Detector Uniformity and artifact Detection
5.2 Collimation, Dead Space and Compression Paddle Position
5.3 AEC Thickness Tracking
5.4 Spatial Resolution
5.5 SNR, CNR and AEC Repeatability
5.6 Image Quality and Radiation Dose
5.7 HVL and Radiation Output
5.8 Tube Voltage and Repeatability
5.9 Printer Check
6.1 Ghost Image Evaluation (Optional)
  1. Soft-Copy Review Workstation:

The Siemens syngoMammoReport Quality Control Manual is supplied with the purchase of the syngoMammoReport. Perform the tests listed in the Siemens syngoMammoReport QC manual or follow the QC program specified by the Review Workstation manufacturer, or follow a program substantially equivalent to either of these.

The acceptance test of syngoMammoReport involves performance of all QC procedures in this Quality Control Manual, ensuring that a basic minimum image quality criteria is met before the system is used for diagnostic purposes. For each part of the acceptance test, action levels that must be met are specified.

syngoMammoReport Quality Control Manual QC Tests:
Test 1: Reflection
Test 2: Overall Evaluation
Test 3: Geometrical distortion (CRT only)
Test 4: Luminance response
Test 5: Luminance uniformity
Test 6: Resolution
Test 7: Noise
  1. Laser Camera: Perform the test specified in section 5.9 of the Siemens Mammomat NovationDR QC Manual or follow the QC procedure recommended by the laser camera manufacturer (Reference section 5.9.3).

E. Fuji FCRm

FCRm MAMMOGRAPHY EQUIPMENT EVALUATIONS (MEE)
UNDER the MAMMOGRAPHY QUALITY STANDARDS ACT

Fujifilm Medical Systems U.S.A., Inc.
Effective June 22, 2008

CURRENT VERSION

This document is effective as of the date written above, and is subject to change or withdrawal without notice. To determine whether this document is current, telephone Fujifilm technical support at (800) 272 8465

This complete document consists of two pages: this page and a second page listing applicable FCRm tests that are required as an MEE and the 21 CFR § 900.12(b) Equipment Regulations.

APPLICABILITY

This document applies in mammography facilities observing the United States Mammography Quality Standards Act (MQSA).

This document applies to all FCRm systems incorporating, but not limited to, the ClearView CSm and ClearView 1m as image readers. This document refers to quality control tests in the FCRm Fuji CR for Mammography Quality Control Manual 3rd Edition: February 2007, document identification 02.2007 897N0602B.

PERSONNEL QUALIFICATIONS

Individuals performing mammography equipment evaluations must meet the requirements laid out in 21 CFR § 900.12(e)(10), i.e. the person must either be a medical physicist or be under the direct supervision of a medical physicist.
To be clear, although the accompanying table lists the tests from the FCRm QC Manual as they are identified in the manual (e.g. weekly-technologist, monthly-technologist, quarterly-technologist, and annual-medical physicist), the tests when performed as part of an MEE must be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.

INTRODUCTION TO THE TABLE

The table on the following page lists the tests that Fujifilm has determined constitute a mammography equipment evaluation (MEE) under 21 CFR § 900.12(e)(10).

The specific tests to be included in an MEE are established separately for the three different situations identified in the numbered columns in the table:

  1. Situation 1) Original installation of FFDM (FCRm CR Console and IP image reader combined with X-ray exposure unit).
  2. Situation 2) When adding or replacing an X-ray system to an FCRm installation.
  3. Situation 3) When adding or replacing an image reader to an FCRm installation.

A test is required to be performed under a situation when an “R” is in the column identifying that situation. A “C*” in a column identifies a test that is conditionally required, according to the noted (“*”) condition, and a dash (“ -”) indicates that test is not part of an MEE for the situation (column in which the dash appears).

Applicable MEE Tests From the FCRm QC Manual and MQSA Regulations
This is page two of a two-page document. For applicability, see page one.
June 22, 2008

LEGEND:

  • R = Required
  • C* = Required Condition
  • - = Not Required
  • Situation Columns
    • S#1 = Situaton #1, Upon installation of FCRm
    • S#2 = Situation #2, Upon adding or replacing an X-ray system to FCRm
    • S#3 = Situation #3, Upon adding or replacing an Image Reader to FCRm
Section # Test Situation
#1
Situation
#2
Situation
#3
Comment
Section B Weekly - Technologist 1 CNR Weekly Check R R R  
2 Phantom Images [ACR MAP] - - - The annual image quality evaluation (15) is performed.
3 Printer QC - - - The annual printer QC test (11) is performed.
4 Monitor QC - - - The annual monitor QC test (12) is performed.
Section C Monthly - Technologist 5 Visual Check List - - -  
Section D Quarterly - Technologist 6 Repeat Analysis - - - Repeat analysis is not possible for new installations.
Section E Semi-Annual - Technologist 7 Compression R R -  
8 Imaging Plate (IP) Fog R C* C* * Only if adding a new IP storage location within the x-ray room
Section F Annual - Medical Physicist 9 Viewing and Viewing Conditions R - -  
10 Printer QC R C* C* * Only if adding a new printer for final diagnosis
11 Monitor QC R C* C* * Only when adding a primary or secondary monitor
12 S value Confirmation R R R  
13 System Resolution R R R  
14 CR Reader Scanner Performance R - R  
15 Mammographic Unit Assembly Evaluation R R -  
16 Collimation Assessment R R -  
17 Automatic Exposure Control (AEC) System Performance Assessment R R -  
18 System Artifact Evaluation R R R  
19 Image Quality Evaluation R R R  
20 Dynamic Range R R R  
21 Primary Erasure (Additive and Multiplicative Lag Effects) R R R  
22 Inter-Plate Consistency R C* C* * Only when adding a new Cassette/IP
23 kVp Accuracy and Reproducibility R R -  
24 Dose R R -  
25 Beam Quality Assessment and Half-value Layer Measurement R R -  
26 Radiation Output R R -  
21 CFR 21 § 911.12(b) Equipment Regulations (1) Prohibited equipment. R R -  
(2) General. R R -  
(3) Motion of tube-image receptor assembly. R R -  
(4) Image receptor sizes. R R - both sizes of imaging plates and cassettes shall be provided
(5) Light fields. R R -  
(6) Magnification. R R -  
(7) Focal spot selection. R R -  
(8) Compression. R R -  
(9) Technique factor selection and display. R R -  
(10) Automatic exposure control. R R -  
(11) X-ray film. C* - C* * when printing films for final interpretation, use printers designated by the manufacturer as appropriate for mammography
(12) Intensifying screens. R R R Fuji BR-BD imaging plates and DM cassettes shall be employed
(13) Film processing solutions. C* - C* * when producing films for final interpretation by wet proceesing, the film processing conditions shall be consistent with the film manufacturer's recommendations
(14) Lighting. C* - - * when final interpretation is by film
(15) Film masking devices. C* - - * when final interpretation is by film