K972271 is an FDA 510(k) clearance for the NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Ml Strategies, Inc. (Boston, US). The FDA issued a Cleared decision on October 28, 1997, 132 days after receiving the submission on June 18, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K972271 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 1997 |
| Decision Date | October 28, 1997 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |