Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart C — Cardiovascular Monitoring Devices](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices) → [21 CFR 870.2215](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2215) → SIU — Predictive Indicator For Long-Term Cardiovascular Outcomes

# SIU · Predictive Indicator For Long-Term Cardiovascular Outcomes

_Cardiovascular · 21 CFR 870.2215 · Class 2_

**Canonical URL:** https://fda.innolitics.com/productcode/SIU

## Overview

- **Product Code:** SIU
- **Device Name:** Predictive Indicator For Long-Term Cardiovascular Outcomes
- **Regulation:** [21 CFR 870.2215](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/870.2215)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

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. It is indicated for adults from 30 to 80 years old who have been referred for CCTA imaging.

## Classification Rationale

FDA concludes that this device should be classified into Class II. This order classifies the device into Class II under the generic name predictive indicator for long-term cardiovascular outcomes, with the establishment of special controls to provide reasonable assurance of the safety and effectiveness of the device type.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [DEN250042](/device/DEN250042.md) | CaRi-Heart | Caristo Diagnostics , Ltd. | Jul 28, 2026 | DENG |

## Top Applicants

- Caristo Diagnostics , Ltd. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/SIU](https://fda.innolitics.com/productcode/SIU)

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