SOPHYCAMERA DSX BODYTRAK
Camera, Scintillation (gamma)
SOPHA MEDICAL SYSTEMS, INC.
The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Sophycamera Dsx Bodytrak.
Pre-market Notification Details
| Device ID | K911346 |
| 510k Number | K911346 |
| Device Name: | SOPHYCAMERA DSX BODYTRAK |
| Classification | Camera, Scintillation (gamma) |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2101 |
| Contact | Randy L Weatherhead |
| Correspondent | Randy L Weatherhead SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2101 |
| Product Code | IYX |
| CFR Regulation Number | 892.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-27 |
| Decision Date | 1991-04-18 |
Trademark Results [SOPHYCAMERA DSX BODYTRAK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SOPHYCAMERA DSX BODYTRAK 74092258 not registered Dead/Abandoned |
Sopha Medical Systems, Inc. 1990-08-29 |
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