K132816 is an FDA 510(k) clearance for the ONCENTRA BRACHY. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Nucletron B.V. (Rice Lake, US). The FDA issued a Cleared decision on June 13, 2014, 277 days after receiving the submission on September 9, 2013.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K132816 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2013 |
| Decision Date | June 13, 2014 |
| Days to Decision | 277 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | MUJ - System, Planning, Radiation Therapy Treatment |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.5050 |