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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 040 Date of Entry 08/14/2015 
FR Recognition Number 12-289
Standard
IEC  62220-1-1 Edition 1.0 2015-03
Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
Scope/Abstract
Specifies the method for the determination of the detective quantum efficiency (DQE) of digital X-ray imaging devices as a function of exposure and of spatial frequency for the working conditions in the range of the medical application as specified by the manufacturer. Is applicable to projection digital X-ray imaging devices producing images in digital format that are used for medical diagnosis. It is restricted to digital X-ray imaging devices that are used for radiographic imaging, such as CR systems, selenium-based systems, flat panel detectors, optically coupled CCD detectors, and digital X-ray image intensifiers used for single exposures.
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
§892.1680 Solid State X-Ray Imager (Flat Panel/Digital Imager) Class 2 MQB
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, August 6, 1999

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
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Radiology
*These are provided as examples and others may be applicable.
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