Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-150: IEC / ISO 10918-1:1994 Technical Corrigendum 1:2005, Information technology -- Digital compression and coding of continuous-tone still images - Part 1: Requirements and guidelines. (Radiology)
Date of Standard: 1994. |
| Addresses of Standards Organizations: |
| 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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| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Medical Image Management Devices, Telemedicine Systems, Image Storage Systems |
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| Processes Affected: |
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| Type of Standard: |
| International, Horizontal |
| Extent of Recognition: |
| Complete standard and any annexes |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.2050 |
System, Image Processing, Radiological |
Class 2 |
LLZ |
| |
|
| Relevant Guidance: |
| Guidance for the Submisson of Premarket Notifications for Medical Image Management Devices. Document issued on: July 27, 2000 |
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| FDA Technical Contact: |
| Kish Chakrabarti |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G308 |
| Silver Spring MD 20993 |
| 301/796-6539 |
| Email: kish.chakrabarti@fda.hhs.gov |
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