The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Rota Camera.
| Device ID | K811715 |
| 510k Number | K811715 |
| Device Name: | ROTA CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SIEMENS GAMMASONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-18 |
| Decision Date | 1981-07-20 |