aiCockpit AI Viewer— 510(k) K241546

Substantially Equivalent

Fovia, Inc.

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

Clearance details

Applicant: Fovia, Inc.
Product code: Code LLZ
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 ↗

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.