# K962153: Digital Image Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: University of Washington
- Decided: Jan 17, 1997 after 227 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. The FDA summary names no predicate by number.

## Indications for use
The intended applications of the software are: 1) to assist in evaluating a patient with suspected heart disease, 2) to measure the effectiveness of therapy, 3) to assess risk or prognosis, and 4) in clinical trials evaluating new therapies.

Source page: https://510kreport.com/device/K962153
Methodology: https://510kreport.com/methodology