# K152038: MammoGRIP

- Pathway: 510(k) (Traditional)
- Applicant: Women'S Imaging Solutions Enterprises, LLC
- Decided: Dec 22, 2015 after 153 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003795 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062141: Mammopad Radiolucent Cushion, Biolucent, Inc. (2006) Summary page 4.

## Indications for use
MammoGRIP aids in positioning during radiologic visualization of the breast.

Source page: https://510kreport.com/device/K152038
Methodology: https://510kreport.com/methodology