The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Rt Elements, Cranial Srs W/ Cones, Multiple Brain Mets Srs, Cranial Srs, Spine Srs, Rt Qa, Dose Review.
| Device ID | K203681 |
| 510k Number | K203681 |
| Device Name: | RT Elements, Cranial SRS W/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Contact | Chiara Cunico |
| Correspondent | Chiara Cunico Brainlab AG Olof-Palme-Str. 9 Munich, DE 81829 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-17 |
| Decision Date | 2021-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481000530 | K203681 | 000 |