Recognition List Number: 025 Publication Date: 10/04/2010
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-212: IEC 62220-1 Edition 1.0 (2003-10), Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency. (Radiology)
Date of Standard: 2003. |
| Address of Standards Organization: |
| International Electrotechnical Commission (IEC) |
| 3, Rue de Varembe' |
| PO Box 131 |
| CH-1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| ALL OFFICES AND DIVISIONS IN CDRH |
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| Devices Affected: |
| Digital X-ray Imaging Devices |
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| Processes Affected: |
| Premarket and postmarket processes |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1650 |
Solid State X-Ray Imager (Flat Panel/Digital Imager) |
Class 2 |
MQB |
| |
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| Relevant Guidance: |
| 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 |
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| FDA Technical Contact: |
| Robert Jennings |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 3102 |
| Silver Spring MD 20993 |
| 301/796-2539 |
| Email: robertj.jennings@fda.hhs.gov |
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