Sonometrics Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Sonometrics Systems, Inc. makes
Sonometrics Systems, Inc. manufactures diagnostic ultrasound devices, including the DIOSCAN for ocular imaging and the GLAUKON for intraocular pressure measurement. The ORBIOGRAPH is a device used for ocular blood flow analysis, supporting ophthalmic diagnostics.
The company’s portfolio consists of Class II medical devices, each authorised via the FDA’s 510(k) clearance process. These devices are listed under the US regulatory framework and are based in the United States.
Catalogue
Dioscan Ref K802341
Regimes: 510(k) Registry: 510(k)Glaukon Ref K812015
Regimes: 510(k) Registry: 510(k)Glaukon Ref K820751
Regimes: 510(k) Registry: 510(k)Orbiograph Ref K781543
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sonometrics Systems, Inc. have in the registry?
The registry currently lists 4 devices for Sonometrics Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sonometrics Systems, Inc.'s devices?
Among its 4 most recently registered devices, Sonometrics Systems, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Sonometrics Systems, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sonometrics Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sonometrics Systems, Inc. in the registry?
The most recently registered devices listed for Sonometrics Systems, Inc. include DIOSCAN, GLAUKON and ORBIOGRAPH.