Cleared Traditional

MammoGRIP

K152038 · Women'S Imaging Solutions Enterprises, LLC · Radiology
Dec 2015
Decision
153d
Days
Class 2
Risk

About This 510(k) Submission

K152038 is an FDA 510(k) clearance for the MammoGRIP, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Women'S Imaging Solutions Enterprises, LLC (Cresskill, US). The FDA issued a Cleared decision on December 22, 2015, 153 days after receiving the submission on July 22, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K152038 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 2015
Decision Date December 22, 2015
Days to Decision 153 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