AmCAD-UT Detection 2.2— 510(k) K180006

Substantially Equivalent

Amcad Biomed Corporation

FDA 510(k) clearance K180006 for AmCAD-UT Detection 2.2, Substantially Equivalent on 2018-08-31. Applicant: Amcad Biomed Corporation.

Clearance details

Applicant: Amcad Biomed Corporation
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2018-01-02
Decision date: 2018-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

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.