Cleared Traditional

K180867 - AmCAD-UO (FDA 510(k) Clearance)

K180867 · Amcad Biomed Corporation · Radiology device

Dec 2018

Decision

270d

Days

Class 2

Risk

K180867 is an FDA 510(k) clearance for the AmCAD-UO. 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 December 28, 2018, 270 days after receiving the submission on April 2, 2018.

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

Submission Details

510(k) Number	K180867 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 02, 2018
Decision Date	December 28, 2018
Days to Decision	270 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF