Radiation-Emitting Products

Download Radiation-Emitting Electronic Product Codes Files

Files

These files are replaced monthly, usually on the 5th of each month.


File Description

FOI_Rad_Emitting_Pcode.txt

 Data Elements
1Product Code (3 characters) unique product identifier
2Product Name (120 characters)
3Radiation Type Code (2 characters)
4Performance Standard (4000 characters)
5Medical specialty Code (2 characters)
6Radiological_Category_code (2 characters)
7Device Definition (2000 characters)

Radiation_Types_List.txt

 Data Elements
1Radiation Type Code (2 characters)
2Radiation Type (60 characters)

Radialogical_Categories_List.txt

 Data Elements
1Radiological Category Code (2 characters)
2Radiological Category (120 characters)

Product Code

System generated three (3) character unique identifier of device.

Product Name

The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. Therefore, the first word in the device name is usually the best search parameter. For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name.

Performance Standard

Performance standard specifies the radiation safety performance standard(s) applicable under FDA’s electronic product radiation control requirements. Any electronic product or medical device emitting radiation may be subject to a performance standard.

The CDRH database links to the appropriate performance standard contained in Title 21, Code of Federal Regulations. If the database references multiple performance standards, all may be applicable. If the database does not reference a performance standard, no standard is applicable.

Radiation Types

Radiation type describes the electronic product radiation emitted from the device, and may include ionizing, optical, microwave or EMF, and acoustic.

Radiation Type CodeRadiation Type
94Ionizing
95Optical
96Microwave EMF
97Acoustic
99N/A

Radiological Category

Radiological Category describes the radiation-emitting electronic products.

Radiological CategoryRadiological Category Code
Analytical X-Ray Systems, Non-Medical14
Cabinet X-Ray Systems, Medical66
Cabinet X-Ray Systems, Non-Medical17
Cargo Non-Intrusive Security Systems57
Cathode Ray Tube (without Electronics Chassis)05
Cold-Cathode Gas Discharge Tubes08
Data Measurement, Transmit, Control Laser Products48
Dental Diagnostic X-Ray Equipment18
Diagnostic Nuclear Medicine Devices26
Diagnostic Ultrasound Device23
Diagnostic X-Ray Equipment (Non-Certified)12
General Optical Products, Medical62
General Optical Products, Non-Medical63
High Voltage Vacuum Switches06
High Voltage Vacuum Tubes04
Household ELF Products36
In Vitro and Other Medical Laser Products50
Industrial Dielectric Heaters27
Industrial Particle Beam Systems38
Industrial X-Ray Systems (Excluding Cabinet13
Industrial X-Ray Systems (Excluding Cabinet)29
Laser Products (Pre-Standard)10
Material Processing Laser Products47
Medical Accelerators11
Medical Diagnostic X-Ray Equipment16
Medical Laser Products34
Mercury Vapor Lamps28
Microwave Communication, Data Transmit, and Measurement Products54
Microwave Diathermy Machines03
Microwave Heating and Drying Products02
Microwave Hyperthermia Therapy Devices33
Microwave Identification, Safety, Security, and Surveillance Products53
Microwave Medical Products52
Microwave Ovens (Food Prep)01
Non-Medical Accelerators65
Nuclear Magnetic Resonance Devices32
Other Demonstration Laser Products40
Other Laser Products22
Other Microwave Products55
Personnel Security Systems56
Positioning Medical Laser Products51
Radioisotope Therapy Devices25
Research, Scientific, Laboratory Laser Products44
Safety, Security, Surveillance Laser Products46
Sonic Medical Products64
Sonic Non-Medical Products35
Sunlamp Products (Certified)30
Sunlamp Products (Pre-Standard)19
Surveying, Leveling, Alignment Laser Products45
TV Receivers & Products Containing Same07
Therapeutic Ultrasonic Devices (Certified)24
Therapeutic X-Ray Systems15
Toy, Novelty, Play Laser Products41
Ultrasonic Medical Devices (Miscellaneous)31
Ultrasound Non-Medical Devices09
Ultraviolet Commercial/Consumer Products61
Ultraviolet Hygiene Products60
Ultraviolet Medical Products58
Ultraviolet Surveillance & Detection Products59
Utility/Peripheral Laser Products49
Veterinary Diagnostic Ultrasonic Products42
Veterinary Therapy Ultrasonic Products43
Veterinary X-Ray Systems37
X-Ray Bone Densitometers39
X-Ray Film and Film Processing Materials21

Medical Specialty

Two letters indicate the medical specialty panel responsible for reviewing the product.

Medical Specialty (Advisory Committee)Regulation No.Medical Specialty Code
AnesthesiologyPart 868AN
CardiovascularPart 870CV
Clinical ChemistryPart 862CH
DentalPart 872DE
Ear, Nose, & ThroatPart 874EN
Gastroenterology & UrologyPart 876GU
General HospitalPart 880HO
HematologyPart 864HE
ImmunologyPart 866IM
MicrobiologyPart 866MI
NeurologyPart 882NE
Obstetrics/GynecologyPart 884OB
OphthalmicPart 886OP
OrthopedicPart 888OR
PathologyPart 864PA
Physical MedicinePart 890PM
RadiologyPart 892RA
General & Plastic SurgeryPart 878SU
Clinical ToxicologyPart 862TX

Regulation Number

The CDRH database links medical devices to the appropriate regulation that contains a product definition and is published in Title 21, Code of Federal Regulations. If the database does not reference a regulation number, the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final.

Device Definition

Definition of device, based upon nomenclature experts which incorporates definition components of device.

Page Last Updated: 03/19/2015
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