Cleared Traditional

Comfort Cover

K161920 · Precision Dynamics Corporation · Radiology
Jul 2016
Decision
2d
Days
Class 2
Risk

About This 510(k) Submission

K161920 is an FDA 510(k) clearance for the Comfort Cover, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Precision Dynamics Corporation (Valencia, US). The FDA issued a Cleared decision on July 15, 2016, 2 days after receiving the submission on July 13, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K161920 FDA.gov
FDA Decision Cleared SESE
Date Received July 13, 2016
Decision Date July 15, 2016
Days to Decision 2 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710