Product code SIU— Cardiovascular
CaRi-Heart
- Classification name
- Predictive Indicator For Long-Term Cardiovascular Outcomes
- Device class
- Class 2
- Regulation
- 21 CFR 870.2215
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease.”
Market context for product code SIU
FDA has cleared device under product code SIU, all in 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SIU
Recent clearances under product code SIU
Data sourced from openFDA. This site is unofficial and independent of the FDA.