# K201250: SQuEEZ Software

- Pathway: 510(k) (Traditional)
- Applicant: Cardiowise, Inc.
- Decided: Dec 18, 2020 after 221 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 32 ancestors in all.
No later device cites it as a predicate yet.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112531: Vitrea CT Myocardial Analysis, Vital Images, Inc. (2011) Summary page 5.

## Indications for use
The SQuEEZ Software is an image analysis software application for cardiac Computer Tomography (CT) studies to assist cardiologists and radiologists in assessing function when producing a cardiac evaluation. The software calculates a Stretch Quantifier for Endocardial Engraved Zones (SQuEEZ) value to highlight and color code the wall motions of the heart. Tools are provided to display regional motion properties of the heart.

Source page: https://510kreport.com/device/K201250
Methodology: https://510kreport.com/methodology