Sopha Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 8
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K952190 | TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE | January 18, 1996 |
| K942837 | DST-XL | January 5, 1995 |
| K921008 | VECTOR SERIES | April 27, 1992 |
| K913641 | SOPHY NXT | December 17, 1991 |
| K911346 | SOPHYCAMERA DSX BODYTRAK | April 18, 1991 |
| K894931 | SOPHYCAMERA DSX RECTANGULAR | October 27, 1989 |
| K872132 | SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS | October 26, 1987 |
| K872297 | DS-7 NUCLEAR MEDICINE GAMMA CAMERA | August 12, 1987 |