AI Metrics— 510(k) K202229

Substantially Equivalent

Ai Metrics, LLC

FDA 510(k) clearance K202229 for AI Metrics, Substantially Equivalent on 2020-12-22. Applicant: Ai Metrics, LLC.

Clearance details

Applicant: Ai Metrics, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-08-07
Decision date: 2020-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoover, AL, 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.