FDA applicant

Bioimagene, Inc.

Cupertino, CA3 decisions2007–20100 recalls

FDA records 3 decisions for Bioimagene, Inc. (Cupertino, CA) from 2007 to 2010: 3 510(k) clearances. Most are in product codes NOT (Microscope, Automated, Image Analysis…) and NQN (Microscope, Automated, Image Analysis…). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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

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

How often FDA has decided Bioimagene, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioimagene, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bioimagene, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?