The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Sophycamera Dsx Rectangular.
| Device ID | K894931 |
| 510k Number | K894931 |
| Device Name: | SOPHYCAMERA DSX RECTANGULAR |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Randy Weatherhead |
| Correspondent | Randy Weatherhead 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 | 1989-08-02 |
| Decision Date | 1989-10-27 |