FDA applicant

Bioptics, Inc.

Tucson, AZ4 decisions2005–20100 recalls

FDA records 4 decisions for Bioptics, Inc. (Tucson, AZ) from 2005 to 2010: 4 510(k) clearances. All are in product code MWP (Cabinet, X-Ray System). Its devices cite 4 predicates, 2 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, radiology panel, where it files most

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

FDA decisions per year

1in 2010

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Bioptics, 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?