Cleared Traditional

K180006 - AmCAD-UT Detection 2.2 (FDA 510(k) Clearance)

K180006 · Amcad Biomed Corporation · Radiology device

Aug 2018

Decision

241d

Days

Class 2

Risk

K180006 is an FDA 510(k) clearance for the AmCAD-UT Detection 2.2. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Amcad Biomed Corporation (Taipei, TW). The FDA issued a Cleared decision on August 31, 2018, 241 days after receiving the submission on January 2, 2018.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K180006 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 02, 2018
Decision Date	August 31, 2018
Days to Decision	241 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF