Sopha Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 8
What Sopha Medical Systems, Inc. makes
Sopha Medical Systems, Inc. manufactures nuclear medicine computer systems, including the VECTOR SERIES, DST-XL, SOPHYCAMERA DSX BODYTRAK, SOPHYCAMERA DSX RECTANGULAR, DS-7 NUCLEAR MEDICINE GAMMA CAMERA, and the SOPHY SERIES OF NUCLEAR MEDICINE COMPUTER SYSTEMS, along with the TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE.
The company's devices are regulated as Class I and Class II medical devices and are listed in the FDA 510(k) database. Sopha Medical Systems, Inc. is based in the US.
Catalogue
Vector Series Ref K921008
Regimes: 510(k) Registry: 510(k)Dst-Xl Ref K942837
Regimes: 510(k) Registry: 510(k)Sophycamera Dsx Bodytrak Ref K911346
Regimes: 510(k) Registry: 510(k)Sophy Nxt Ref K913641
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ds-7 Nuclear Medicine Gamma Camera Ref K872297
Regimes: 510(k) Registry: 510(k)Sophycamera Dsx Rectangular Ref K894931
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sopha Medical Systems, Inc. have in the registry?
The registry currently lists 8 devices for Sopha Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sopha Medical Systems, Inc.'s devices?
Among its 8 most recently registered devices, Sopha Medical Systems, Inc. has devices listed in FDA 510(k) (8 devices).
What risk classes do Sopha Medical Systems, Inc.'s devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sopha Medical Systems, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sopha Medical Systems, Inc. in the registry?
The most recently registered devices listed for Sopha Medical Systems, Inc. include VECTOR SERIES, DST-XL, SOPHYCAMERA DSX BODYTRAK and SOPHY NXT.