K991526 is an FDA 510(k) clearance for the ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Imagyn Medical Technologies, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on June 17, 1999, 45 days after receiving the submission on May 3, 1999.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K991526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1999 |
| Decision Date | June 17, 1999 |
| Days to Decision | 45 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |