The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Orbitor Ii Counter Balance Camera.
| Device ID | K850397 |
| 510k Number | K850397 |
| Device Name: | ORBITOR II COUNTER BALANCE CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Contact | Joseph P Stowell |
| Correspondent | Joseph P Stowell SIEMENS GAMMASONICS, INC. 2000 NUCLEAR DR. Des Plaines, IL 60018 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-03-26 |