Fmi Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Fmi Medical Systems, Inc. makes
Fmi Medical Systems, Inc. manufactures the CURA 778, a medical imaging device, and the CURA 16 and ScintCare CT16, which appear to be computed tomography (CT) scanners designed for specific diagnostic imaging applications.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Cura 778 Ref K192590
Regimes: 510(k) Registry: 510(k)CURA 16; ScintCare CT16 Ref K173076
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fmi Medical Systems, Inc. have in the registry?
The registry currently lists 2 devices for Fmi Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fmi Medical Systems, Inc.'s devices?
Among its 2 most recently registered devices, Fmi Medical Systems, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Fmi Medical Systems, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fmi Medical Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Fmi Medical Systems, Inc. in the registry?
The most recently registered devices listed for Fmi Medical Systems, Inc. include CURA 778 and CURA 16; ScintCare CT16.