O.N. Diagnostics
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O.N. Diagnostics is a medical device manufacturer, with 5 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 15 Nov 2026.
- Devices
- 5
Registry facts
- Registries
- FDA 510(k) 3
- FDA GUDID 2
- Device classes
- FDA Class II 5
What O.N. Diagnostics makes
O.N. Diagnostics manufactures radiology DICOM image processing application software, including products such as VirtuOst, VirtuOst VFA, and related variants.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
VirtuOst Ref K220402
Regimes: 510(k) Registry: 510(k)Virtuost Ref K113725
Regimes: 510(k) Registry: 510(k)VirtuOst Vertebral Fracture Assessment Ref K171435
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does O.N. Diagnostics have in the registry?
The registry currently lists 5 devices for O.N. Diagnostics. Devices recorded under merged duplicate company entries are counted once.
Which registries list O.N. Diagnostics's devices?
Among its 5 most recently registered devices, O.N. Diagnostics has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do O.N. Diagnostics's devices fall under?
Among its 5 most recently registered devices, the classes recorded for O.N. Diagnostics's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from O.N. Diagnostics in the registry?
The most recently registered devices listed for O.N. Diagnostics include VirtuOst A, VirtuOst VFA, VirtuOst and VirtuOst Vertebral Fracture Assessment.