510(k) Report

FDA applicant

Ziosoft, Inc.

Redwood City, CA6 decisions2007–20200 recalls

FDA records 6 decisions for Ziosoft, Inc. (Redwood City, CA) from 2007 to 2020: 6 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 18 predicates, 1 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 Ziosoft, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 12008: 12009: 22018: 12020: 1
2007high 2 (2009) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ziosoft, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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