FDA applicant

LVIS Corporation

Palo Alto, CA3 decisions2023–20250 recalls

FDA records 3 decisions for LVIS Corporation (Palo Alto, CA) from 2023 to 2025: 3 510(k) clearances. Most are in product codes OMB (Automatic Event Detection Software For…) and OLX (Source Localization Software For…). Its devices cite 2 predicates, 0 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, neurology panel, where it files most

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

FDA decisions per year

1in 2025

2023high 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — LVIS Corporation by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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LVIS Corporation

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?