Recognition List Number: 014 Publication Date: 03/31/2006
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 12-141: IEEE N42.13-2004, Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides. (Radiology)
Date of Standard: 2004. |
| Address of Standards Organization: |
| Institute of Electrical and Electronic Engineers (IEEE) |
| 345 East 47th Street |
| New York, NY 10017 |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Radionuclide Dose Calibrators |
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| Processes Affected: |
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| Type of Standard: |
| Vertical, National |
| 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 |
| §892.1360 |
Calibrator, Dose, Radionuclide |
Class 2 |
KPT |
| |
|
| Relevant Guidance: |
| Guidance for Industry-Guidance for the Submission of Premarket Notification for Radionuclide Dose Calibrators. Document Issued on November 20, 1998 |
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| 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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