Cleared Traditional

K152038 - MammoGRIP

K152038 is an FDA 510(k) clearance for MammoGRIP, manufactured by Women'S Imaging Solutions Enterprises, LLC. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K152038 · Women'S Imaging Solutions Enterprises, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2015
Decision
153d
Days
Class 2
Risk

K152038 is an FDA 510(k) clearance for the MammoGRIP. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Women'S Imaging Solutions Enterprises, LLC (Cresskill, US). The FDA issued a Cleared decision on December 22, 2015 after a review of 153 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K152038

510(k) Number K152038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 107d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Namsa
Erika Huffman

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZH System, X-ray, Mammographic

All 141
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