FDA applicant

Bio-Scan S.A

Stamford, CT1 decision2002–20020 recalls

FDA records 1 decision for Bio-Scan S.A (Stamford, CT) in 2002: 1 510(k) clearance. All are in product code MQB (Solid State X-Ray Imager (Flat Panel/Digital…). 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 Bio-Scan S.A’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bio-Scan S.A since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bio-Scan S.A by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Bio-Scan S.A

Which product codes does it file in?

What has FDA decided for it lately?