AXIS PACS, HMS PACS— 510(k) K103679

Substantially Equivalent

Axis Health Care, LLC

FDA 510(k) clearance K103679 for AXIS PACS, HMS PACS, Substantially Equivalent on 2011-03-03. Applicant: Axis Health Care, LLC.

Clearance details

Applicant: Axis Health Care, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2010-12-17
Decision date: 2011-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montgomery, 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.