Recognition List Number: 026 Publication Date: 03/18/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-222: IEC 61223-3-5 First edition 2004-08, Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment. (Radiology)
Date of Standard: 2004. |
| 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: |
| OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR) | | |
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| Devices Affected: |
| Computed Tomography X-ray System |
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| Processes Affected: |
| 510(k), PMA, Device Evaluation, MQSA standards, Radiological Health Regulations |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1750 |
System, X-Ray, Tomography, Computed |
Class 2 |
JAK |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Iacovos Kyprianou |
| FDA/CDRH/OSEL |
| 10903 New Hampshire Avenue Building 62, Room 3109 |
| Silver Spring MD 20993 |
| 301/796-2601 |
| Email: iacovos.kyprianou@fda.hhs.gov |
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