FDA applicant

Ultrasound AI

Greenwood Village, CO1 decision2026–20260 recalls

FDA records 1 decision for Ultrasound AI (Greenwood Village, CO) in 2026: 1 De Novo grant. All are in product code SHE (Radiological Software System For Delivery Date…). 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 Ultrasound AI’s devices, and how often a recall has named them.

FDA decisions per year

1in 2026

2026high 1 (2026)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2026.

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

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Other applicant names beginning “Ultrasound”

FDA records each applicant name separately; these may or may not be the same firm.

Ultrasound Medical Devices, Inc. 2 Ultrasound Biotechnology (Shanghai) Co., Ltd. 1

Ultrasound AI

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Ultrasound”