ADAS 3D— 510(k) K191125

Substantially Equivalent

Galgo Medical S.L

FDA 510(k) clearance K191125 for ADAS 3D, Substantially Equivalent on 2020-01-15. Applicant: Galgo Medical S.L.

Clearance details

Applicant: Galgo Medical S.L
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2019-04-29
Decision date: 2020-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barcelona, ES

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.