Radiation-Emitting Products

Mammographic Image Identification

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900.12(c)(5)(i),(ii),(iii),(iv),(v),(vi),(vii): Mammographic image identification. Each mammographic image shall have the following information indicated on it in a permanent, legible, and unambiguous manner and placed so as not to obscure anatomic structures:

(i)  Name of patient and an additional patient identifier.

(ii) Date of examination.

(iii) View and laterality. This information shall be placed on the image in a position near the axilla. Standardized codes specified by the accreditation body and approved by FDA in accordance with 900.3(b) or 900.4(a)(8) shall be used to identify view and laterality.

(iv) Facility name and location. At a minimum, the location shall include the city, State, and zip code of the facility.

(v) Technologist identification.

(vi) Cassette/screen identification.

(vii) Mammography unit identification, if there is more than one unit in the facility.

  1. Do I have to label all my films with the mAs, kVp, compressed breast thickness or compression force used?
  2. Would the use of stickers meet the requirements of film labeling as stated in 900.12(c)(5)?
  3. What is meant by "cassette/screen identification" in 900.12(c)(5)(vi) and does the type of screen need to be identified on each film?
  4. We have limited space in our film flasher and do not want to use "stick-on" labels. Can we abbreviate our facility name and address?
  5. When we display a breast image on our monitor for final interpretation the identifying information is not displayed (view and laterality, technologist identification, patient name, etc.), but this information does appear on the hard copy film. Is this acceptable?


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Page Last Updated: 07/25/2014
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