# K031574: Squeeze-Ease Mammography Cushion

- Pathway: 510(k) (Traditional)
- Applicant: S & S X-Ray Products, Inc.
- Decided: Aug 4, 2003 after 76 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: 1 generation back to K003795 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003795: Biolucent Mammography Cushion, Biolucent, Inc. (2001) Summary page 1.

## Indications for use
The Squeeze-EaseTM Mammography Cushion provides padding for patient comfort during x-ray visualization of the breast.

Source page: https://510kreport.com/device/K031574
Methodology: https://510kreport.com/methodology