Data / Medical devices / United States / O.N. Diagnostics, LLC
O.N. Diagnostics, LLC: FDA-registered device maker in Berkeley, CA, United States, 2 510(k) clearances
O.N. Diagnostics, LLC is registered with the FDA (registration 3010687441) in Berkeley, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 3, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010687441
- Address
- 1936 University Ave. Suite 280, Berkeley, CA, United States, 94704
- Owner or operator
- O.N. Diagnostics, LLC (10045946)
- Roles
- Manufacturer
- First device listed
- January 16, 2014
- Registered through
- 2026
- Brand names listed
- VirtuOst, VirtuOst Bone Strength Assessment, VirtuOst Vertebral Fracture Assessment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 3, 2018 | K171435 | VirtuOst Vertebral Fracture Assessment | LLZ | Substantially Equivalent | O.N. Diagnostics, LLC | accessdata.fda.gov |
| September 13, 2012 | K113725 | VIRTUOST | KGI | Substantially Equivalent | O.N. Diagnostics | accessdata.fda.gov |
Compare with other makers
Updated August 3, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.