FDA applicant

Mirabel Medical Systems, Inc.

Austin1 decision1999–19990 recalls

FDA records 1 decision for Mirabel Medical Systems, Inc. (Austin) in 1999: 1 original PMA approval. All are in product code NCL (Imager, Breast, Electrical Impedance). 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 Mirabel Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mirabel Medical Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Mirabel Medical Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?