K852023 is an FDA 510(k) clearance for the CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41. This device is classified as a Source, Brachytherapy, Radionuclide (Class II - Special Controls, product code KXK).
Submitted by Syncor Intl. Corp. (Sylmar, US). The FDA issued a Cleared decision on August 21, 1985, 105 days after receiving the submission on May 8, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5730.
| 510(k) Number | K852023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 1985 |
| Decision Date | August 21, 1985 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KXK — Source, Brachytherapy, Radionuclide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5730 |