# K231335: Cleerly ISCHEMIA

- Pathway: 510(k) (Traditional)
- Applicant: Cleerly, Inc.
- Decided: Sep 8, 2023 after 123 days
- Product code: QXZ (Adjunctive Epicardial Vascular Physiologic Status Indicator)
- Device class: 2
- Regulation: 21 CFR 870.2200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K962603 (1997). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222463: EchoGo Heart Failure, Ultromics Limited (2022) Summary page 4.

## Indications for use
Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool, indicated as a diagnostic aid for patients undergoing CT analysis using Cleerly Labs software. When utilized by an interpreting healthcare provider, this software tool provides information that may be useful in detecting likely ischemia associated with coronary artery disease. Patient management decisions should not be made solely on the results of the Cleerly ISCHEMIA analysis.

Source page: https://510kreport.com/device/K231335
Methodology: https://510kreport.com/methodology