K203681 is an FDA 510(k) clearance for the RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review. This device is classified as a System, Planning, Radiation Therapy Treatment (Class II - Special Controls, product code MUJ).
Submitted by Brainlab AG (Munich, DE). The FDA issued a Cleared decision on April 9, 2021, 113 days after receiving the submission on December 17, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.5050.
| 510(k) Number | K203681 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2020 |
| Decision Date | April 09, 2021 |
| Days to Decision | 113 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 |