# K032531: Chase Cardiac Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Chase Medical, Inc.
- Decided: Feb 2, 2004 after 171 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

Source page: https://510kreport.com/device/K032531
Methodology: https://510kreport.com/methodology