The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Iplan Rt Image.
| Device ID | K080886 |
| 510k Number | K080886 |
| Device Name: | IPLAN RT IMAGE |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG KAPELLENSTRASSE 12 Feldkirchen, DE 85622 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-31 |
| Decision Date | 2008-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056481140670 | K080886 | 000 |
| 04056481000639 | K080886 | 000 |