510(k) Report

FDA applicant

Stentor, Inc.

San Leandro, CA3 decisions1999–20047 recalls

FDA records 3 decisions for Stentor, Inc. (San Leandro, CA) from 1999 to 2004: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 6 predicates, 0 of them its own earlier devices. 7 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, radiology panel, where it files most

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

FDA decisions per year

No FDA decision for Stentor, Inc. since 2007.

Recalls per year

1in 2011

2007: 12008: 42011: 1
2007high 4 (2008) · low 0 (2009)2026

Class I Class II/III not classified

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

Planning a device like Stentor, 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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Other applicant names beginning “Stentor”

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