The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Neurofocal Collimator.
| Device ID | K891266 |
| 510k Number | K891266 |
| Device Name: | NEUROFOCAL COLLIMATOR |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | W Henkelman |
| Correspondent | W Henkelman SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-08 |
| Decision Date | 1989-04-17 |