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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 020 Date of Entry 09/09/2008 
FR Recognition Number 12-165
NEMA  XR 22-2006 (R2020)
"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
This document defines the minimum set of Quality Control (QC) tests to be applied to the [Manufacturer to enter commercial name], a [Manufacturer to specify display or workstation] labeled for final interpretation of images acquired using a full-field digital mammography (FFDM) image acquisition system. This document is intended to constitute an element of the Quality Assurance Plan (QAP) of the mammographic facility.

Except for the Phantom Image Quality Test, Sec. 3.5, these tests are intended to monitor the performance of the [Manufacturer to specify display or workstation] as a component of the full-field digital mammography system and not the performance of the system as a whole. Hence, a characteristic such as compatibility of the component with the communication protocols used in an imaging network is not an element of these tests.

These tests are intended to monitor the consistency over time of the device's performance. While they may be included as elements of acceptance testing, they are not intended to represent the entirety of an acceptance test
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§892.1715 Full Field Digital, System, X-Ray, Mammographic Class 2 MUE
§892.2050 System, Image Processing, Radiological Class 2 LLZ
900.12(e)(6) Mammography
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry
Guidance for the Submission of Premarktet Notifications for Medical Image Management Devices. Document issued on: July 27, 2000

Premarket Applications for Digital Mammography Systems; Final Guidance for Industry and FDA. Document issued on February 16, 2001

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
Standards Development Organization
NEMA National Electrical Manufacturers Association https://www.nema.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.