The following data is part of a premarket notification filed by Brainlab Ag with the FDA for Iplan Rt Dose.
| Device ID | K053584 |
| 510k Number | K053584 |
| Device Name: | IPLAN RT DOSE |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-23 |
| Decision Date | 2006-07-12 |
| Summary: | summary |