The following data is part of a premarket notification filed by Siemens Gammasonics, Inc. with the FDA for Cardiac Camera.
| Device ID | K833811 |
| 510k Number | K833811 |
| Device Name: | CARDIAC CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SIEMENS GAMMASONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-14 |
| Decision Date | 1983-12-27 |