Prognosys Medical Systems Private Limited
IndiaFDA applicant, unverified
- Devices
- 7
What Prognosys Medical Systems Private Limited makes
Prognosys Medical Systems designs and manufactures stationary and portable radiographic imaging systems, including the ProRad 2FC and ProRad 3NC for fixed installations, as well as the PRORAD ATLAS ULTRAPORTABLE and ATLAS ULTRAPORTABLE PLUS for mobile use. Their product line also includes X-ray flat panel detectors paired with digital radiography control systems (DROC).
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
PRORAD X-Ray Flat Panel Detector with DROC Ref K240771
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 872343077
- [email protected]
- Phone
- 8049325700
Frequently asked questions
How many devices does Prognosys Medical Systems Private Limited have in the registry?
The registry currently lists 7 devices for Prognosys Medical Systems Private Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Prognosys Medical Systems Private Limited's devices?
Among its 7 most recently registered devices, Prognosys Medical Systems Private Limited has devices listed in FDA 510(k) (3 devices) and FDA GUDID (4 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Prognosys Medical Systems Private Limited's devices fall under?
Among its 7 most recently registered devices, the classes recorded for Prognosys Medical Systems Private Limited's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Prognosys Medical Systems Private Limited in the registry?
The most recently registered devices listed for Prognosys Medical Systems Private Limited include PRORAD 3NC A90-3NC-0001, PRORAD 2FC A60-2FC-0001, PRORAD ATLAS ULTRAPORTABLE A86-ATL-0001 and PRORAD ATLAS ULTRAPORTABLE PLUS A87-ATL-0001.