aiCockpit AI Viewer— 510(k) K241546

Name: FDA 510(k) clearance K241546
Creator: U.S. Food and Drug Administration
Published: 2025-02-26

Substantially Equivalent

Fovia, Inc.

FDA 510(k) clearance K241546 for aiCockpit AI Viewer, Substantially Equivalent on 2025-02-26. Applicant: Fovia, Inc.. Device class: 2.

Clearance details

Applicant: Fovia, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-05-31
Decision date: 2025-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ross, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.