The following data is part of a premarket notification filed by Sopha Medical Systems, Inc. with the FDA for Transmission Attenuation Correction (tac) Package.
| Device ID | K952190 |
| 510k Number | K952190 |
| Device Name: | TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SOPHA MEDICAL SYSTEMS, INC. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Contact | Lonnie Mixon |
| Correspondent | Lonnie Mixon SOPHA MEDICAL SYSTEMS, INC. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-09 |
| Decision Date | 1996-01-18 |