The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Sophy Nxt.
| Device ID | K913641 |
| 510k Number | K913641 |
| Device Name: | SOPHY NXT |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2101 |
| Contact | Randy Weatherhead |
| Correspondent | Randy Weatherhead SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2101 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-13 |
| Decision Date | 1991-12-17 |