Recognition List Number: 017 Publication Date: 05/21/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-34: IEC 60601-2-7 (1998), Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators. (Radiology)
Date of Standard: 1998. |
| 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 DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Diagnostic X-ray High Voltage Generator |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes with specific national alterations for areas not covered by 21 CFR Subchapter J (1000, et al.) |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1700 |
Generator, High-Voltage, X-Ray, Diagnostic |
Class 1 |
IZO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.1720 |
System, X-Ray, Mobile |
Class 2 |
IZL |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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| FDA Technical Contact: |
| Richard V. Kaczmarek |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room 4536 |
| Silver Spring MD 20993 |
| 301/796-5891 |
| Email: richard.kaczmarek@fda.hhs.gov |
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