Cleared Traditional

K180125 - PowerLook Density Assessment Software (FDA 510(k) Clearance)

K180125 · Icad, Inc. · Radiology device

Apr 2018

Decision

79d

Days

Class 2

Risk

K180125 is an FDA 510(k) clearance for the PowerLook Density Assessment Software. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Icad, Inc. (Nashua, US). The FDA issued a Cleared decision on April 5, 2018, 79 days after receiving the submission on January 16, 2018.

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

Submission Details

510(k) Number	K180125 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 16, 2018
Decision Date	April 05, 2018
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF