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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 12-166
NEMA  XR 23-2006 (R2020)
"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices 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 of hardcopy device], a hardcopy output device that receives images from an FFDM system, and reproduces them on [Manufacturer to enter description of hardcopy medium] for final interpretation. It should be considered as one element of the mammography facility's Quality Assurance Plan.

The tests in this manual generally focus on device constancy, that is, the ability of the hardcopy device to maintain its expected imaging performance over time. They do not address system quality control, for example, the ability of the various system components (image receptor, acquisition workstation, diagnostic workstations, hardcopy output device) to communicate properly with each other, and to use the communicated information correctly. Such system QC activities are assumed to have occurred during initial system installation, initial system acceptance, or as part of a Mammography Equipment Evaluation (see 4.11).
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
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.