# O.N. Diagnostics

> Medical device manufacturer record on deviCERTS, compiled from public registries. 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.

- Canonical page: <https://devicerts.com/manufacturers/o-n-diagnostics>
- Also registered as: O.N. DIAGNOSTICS, LLC
- Country: not established
- Role: Manufacturer

## Figures

- Devices: 5
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA 510(k) 3, FDA GUDID 2
- Device classes: FDA Class II 5

## Devices

The first 5 of 5, in the order of the canonical page, which lists them all.

- [VirtuOst A](https://devicerts.com/devices/virtuost-a) · Class II · GUDID · status: Active
- [VirtuOst VFA](https://devicerts.com/devices/virtuost-vfa-a) · Class II · GUDID · status: Active
- [VirtuOst](https://devicerts.com/devices/virtuost-kgi-k220402) · ref K220402 · Class II · 510(k) · status: Active · decision 2023-05-19
- [Virtuost](https://devicerts.com/devices/virtuost-kgi) · ref K113725 · Class II · 510(k) · status: Active · decision 2012-09-13
- [VirtuOst Vertebral Fracture Assessment](https://devicerts.com/devices/virtuost-vertebral-fracture-assessment-llz) · ref K171435 · Class II · 510(k) · status: Active · decision 2018-08-03

## Source and citation

- Cite as: O.N. Diagnostics. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/o-n-diagnostics (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA GUDID](https://accessgudid.nlm.nih.gov/)
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/o-n-diagnostics.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/o-n-diagnostics
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.