FDA applicant

Digisonics, Inc.

Houston, TX3 decisions1980–19975 recalls

FDA records 3 decisions for Digisonics, Inc. (Houston, TX) from 1980 to 1997: 3 510(k) clearances. Most are in product codes HEM (Imager, Ultrasonic Obstetric-Gynecologic) and LLZ (System, Image Processing, Radiological). 5 recalls are linked to its devices.

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

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Digisonics, Inc. since 2007.

Recalls per year

1in 2023

2007high 2 (2009) · low 0 (2010)2026

Class I Class II/III not classified

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

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Digisonics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?