The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Dst-xl.
| Device ID | K942837 |
| 510k Number | K942837 |
| Device Name: | DST-XL |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 7155 COLUMBIA GATEWAY DR. Columbia, MD 21046 -2101 |
| Contact | Colin J Mcnaught |
| Correspondent | Colin J Mcnaught 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 | 1994-06-15 |
| Decision Date | 1995-01-05 |