Isono Health Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3042585081
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
ATUSA™ Automated 3D Breast Ultrasound System Ref K213620
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3042585081
- Address
- 538 Oakmead Pkwy, Sunnyvale, CA, 94085
Frequently asked questions
How many devices does ISONO HEALTH INC. have in the registry?
The registry currently lists 1 device for ISONO HEALTH INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list ISONO HEALTH INC.'s devices?
Among its 1 most recently registered device, ISONO HEALTH INC. has devices listed in FDA 510(k) (1 device).
What risk classes do ISONO HEALTH INC.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for ISONO HEALTH INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ISONO HEALTH INC. in the registry?
The most recently registered devices listed for ISONO HEALTH INC. include ATUSA™ Automated 3D Breast Ultrasound System.