| 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 |
| Recognition Date | 2010-10-04 |
| Recognition List | 025 |
| Recognition Number | 12-215 |
| Extent | Complete standard |
| Standards Orgs | IEC International Electrotechnical Commission http://www.iec.ch/ |
| STG | Radiology |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| Regulation Number | Device Name | Device Class | Product Code |
| §892.1680 | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Class 2 | MQB |
| 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 |