K914281 is an FDA 510(k) clearance for the I-125 SEEDS, CODE: 6711. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging (Arlington Heights, US). The FDA issued a Cleared decision on November 22, 1991, 59 days after receiving the submission on September 24, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K914281 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 1991 |
| Decision Date | November 22, 1991 |
| Days to Decision | 59 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 |