The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Modeification To Iplan Rt Dose.
| Device ID | K080888 |
| 510k Number | K080888 |
| Device Name: | MODEIFICATION TO IPLAN RT DOSE |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Carsten Raupach |
| Correspondent | Carsten Raupach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481138608 | K080888 | 000 |
| 04056481000592 | K080888 | 000 |