AmCAD-UV— 510(k) K170069

Name: FDA 510(k) clearance K170069
Creator: U.S. Food and Drug Administration
Published: 2017-04-26

Substantially Equivalent

Amcad Biomed Corporation

FDA 510(k) clearance K170069 for AmCAD-UV, Substantially Equivalent on 2017-04-26. Applicant: Amcad Biomed Corporation. Device class: 2.

Clearance details

Applicant: Amcad Biomed Corporation
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2017-01-09
Decision date: 2017-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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K203555 — AmCAD-UT2021-09-08
K180867 — AmCAD-UO2018-12-28
K180006 — AmCAD-UT Detection 2.22018-08-31
K162574 — AmCAD-US2017-05-30

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.