The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Rt Elements, Cranial Srs, Spine Srs, Multiple Brain Mets Srs, Rt Qa, Adaptive Hybrid Surgery Analysis, Dose Review.
| Device ID | K190664 |
| 510k Number | K190664 |
| Device Name: | RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Brainlab AG Olof-Palme-Str. 9 München, DE 81829 |
| Contact | Rainer Birkenbach |
| Correspondent | Alexander Schwiersch Brainlab AG Olof-Palme-Str. 9 München, DE 81829 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-15 |
| Decision Date | 2019-04-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481142094 | K190664 | 000 |