510(k) Report

FDA applicant

O.N. Diagnostics

Berkeley, CA3 decisions2012–20230 recalls

FDA records 3 decisions for O.N. Diagnostics (Berkeley, CA) from 2012 to 2023: 3 510(k) clearances. Most are in product codes KGI (Densitometer, Bone) and LLZ (System, Image Processing, Radiological). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “O.N. Diagnostics, LLC”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided O.N. Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2012: 12018: 12023: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — O.N. Diagnostics by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • KGIDensitometer, Bone2decisions
  • LLZSystem, Image Processing, Radiological1decision

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113725VirtuostO.N. Diagnostics · 20121cites it

What has FDA decided for it lately?

  • K220402VirtuOstO.N. Diagnostics · 2023
  • K171435VirtuOst Vertebral Fracture AssessmentO.N. Diagnostics, LLC · 2018
  • K113725VirtuostO.N. Diagnostics · 2012

All 2 as O.N. Diagnostics →The one decision as O.N. Diagnostics, LLC →