Recognition List Number: 022 Publication Date: 09/08/2009
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-146: IEC 60601-2-17 (2004), Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading 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 DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Remote Controlled Radionuclide Applicator Systems |
|
| Processes Affected: |
| 510(K), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
| Complete standard and any annexes with specific national alterations |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §892.5700 |
System, Applicator, Radionuclide, Remote-Controlled |
Class 2 |
JAQ |
| |
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| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| John Chen |
| FDA/CDRH/OIVD |
| 10903 New Hampshire Avenue Building 66, Room G302 |
| Silver Spring MD 20993 |
| 301/796-6540 |
| Email: john.chen@fda.hhs.gov |
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