AMCAD-UT DETECTION MODEL 2.0— 510(k) K122536

Substantially Equivalent

Lin & Associates, LLC

FDA 510(k) clearance K122536 for AMCAD-UT DETECTION MODEL 2.0, Substantially Equivalent on 2013-10-03. Applicant: Lin & Associates, LLC.

Clearance details

Applicant: Lin & Associates, LLC
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2012-08-20
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potomac, MD, 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.