MD.ai Viewer— 510(k) K223425

Substantially Equivalent

Mdai, Inc.

FDA 510(k) clearance K223425 for MD.ai Viewer, Substantially Equivalent on 2023-02-10. Applicant: Mdai, Inc..

Clearance details

Applicant: Mdai, Inc.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2022-11-14
Decision date: 2023-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, 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.