The following data is part of a premarket notification filed by Brainlab, Inc. with the FDA for Exactrac (brainlab Patient Positioning System).
| Device ID | K983660 |
| 510k Number | K983660 |
| Device Name: | EXACTRAC (BRAINLAB PATIENT POSITIONING SYSTEM) |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | BRAINLAB, INC. 3100 HANSEN WAY BUILDING 4A, MAILSTOP E233 Palo Alto, CA 94304 |
| Contact | Eric Lindquist |
| Correspondent | Eric Lindquist BRAINLAB, INC. 3100 HANSEN WAY BUILDING 4A, MAILSTOP E233 Palo Alto, CA 94304 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-19 |
| Decision Date | 1999-07-14 |