The following data is part of a premarket notification filed by Brainlab, Ag with the FDA for Intuition Image.
| Device ID | K032511 |
| 510k Number | K032511 |
| Device Name: | INTUITION IMAGE |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Contact | Rainer Birkenbach |
| Correspondent | Rainer Birkenbach BRAINLAB, AG AMMERTHALSTRASSE 8 Heimstetten, DE 85551 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-14 |
| Decision Date | 2004-01-21 |
| Summary: | summary |