The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Ds-7 Nuclear Medicine Gamma Camera.
| Device ID | K872297 |
| 510k Number | K872297 |
| Device Name: | DS-7 NUCLEAR MEDICINE GAMMA CAMERA |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Phyllis C Dillinger |
| Correspondent | Phyllis C Dillinger SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-16 |
| Decision Date | 1987-08-12 |