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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 025 Date of Entry 10/04/2010 
FR Recognition Number 12-215
IEC  62494-1 Edition 1.0 (2008-08)
Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
This part of IEC 62494 specifies definitions and requirements for the EXPOSURE INDEX of images acquired with DIGITAL X-RAY IMAGING SYSTEMS.

This standard is applicable to DIGITAL X-RAY IMAGING SYSTEMS used in general radiography for producing PROJECTION X-ray images for general applications, such as, but not exclusively:

computed radiography (CR) systems based on stimulable phosphors;

flat-panel detector based systems;

charge-coupled device (CCD) based systems.

Image intensifier based systems and systems for mammographic or dental application are not covered in this first edition.

This standard defines the EXPOSURE INDEX only for images generated with a single IRRADIATION event. Images generated from multiple IRRADIATIONS (e.g., tomosynthetic or dualenergy images, multiple views on a single CR plate) are not covered.
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.
FDA Technical Contact
 James Graves
Standards Development Organization
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.