Recognition List Number: 013 Publication Date: 10/31/2005
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-6: IEC 60806 (R1984), Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis. (Radiology)
Date of Standard: 1984. |
| 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: |
| X-Ray Tubes, Diagnostic X-Ray Systems |
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| Processes Affected: |
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| Type of Standard: |
| International, Vertical |
| 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 |
| §892.1760 |
Assembly, Tube Housing, X-Ray, Diagnostic |
Class 1 |
ITY |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
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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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