AMALGA PACS— 510(k) K023246

Substantially Equivalent

Global Care Solutions, S.A.

FDA 510(k) clearance K023246 for AMALGA PACS, Substantially Equivalent on 2002-12-23. Applicant: Global Care Solutions, S.A..

Clearance details

Applicant: Global Care Solutions, S.A.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2002-09-30
Decision date: 2002-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aubrey, TX, US

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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.