FDA applicant

Zonare Medical Systems, Inc.

Mountain View, CA6 decisions2008–20150 recalls

FDA records 6 decisions for Zonare Medical Systems, Inc. (Mountain View, CA) from 2008 to 2015: 6 510(k) clearances. All are in product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic). Its devices cite 17 predicates, 8 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 Zonare Medical Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2008high 2 (2015) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Zonare Medical Systems, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Zonare Medical Systems, 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?