# DEN250042: CaRi-Heart

- Pathway: De Novo (Direct)
- Applicant: Caristo Diagnostics, Ltd.
- Decided: Jul 28, 2026 after 327 days
- Product code: SIU (Predictive Indicator For Long-Term Cardiovascular Outcomes)
- Device class: 2
- Regulation: 21 CFR 870.2215
- 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. De Novo decisions do not claim a predicate device.

## Indications for use
CaRi-Heart is a software device used to produce analysis results to assist Healthcare Professionals in patient management. It helps operators assess vascular inflammation from coronary computed tomography angiography (CCTA) images and measure risk of cardiovascular mortality due to coronary inflammation and other clinical risk factors. CaRi-Heart and its analysis results are indicated for adults from 30 to 80 years old who have been referred for CCTA imaging. CaRi-Heart is to be used by trained operators. CaRi-Heart analysis results are to be used by Healthcare Professionals. CaRi-Heart analysis results should be reviewed with other clinical information which may include, but is not limited to: the patient's original CT images, clinical history, symptoms, clinical risk factors, results of other diagnostic tests, and the clinical judgement of appropriately qualified Healthcare Professionals.

Source page: https://510kreport.com/device/DEN250042
Methodology: https://510kreport.com/methodology