Recognition List Number: 018 Publication Date: 09/12/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-63: IEC 60601-2-43 - Ed. 1.0, Medical electrical equipment - Part 2-43: Particular requirements for the safety of X-ray equipment for interventional procedures. (Radiology)
Date of Standard: 2000. |
| 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: |
| X-ray Equipment Interventional Procedures |
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| Processes Affected: |
| 510(k)s, PMAs, IDEs, HDEs |
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| Type of Standard: |
| International, Horizontal |
| 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 |
| §892.1650 |
System, X-Ray, Fluoroscopic, Image-Intensified |
Class 2 |
JAA |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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