510(k) DEN250042
DEN250042 is an FDA 510(k) premarket notification submitted by Caristo Diagnostics , Ltd. for the device "CaRi-Heart". The FDA issued a decision of De Novo Granted on Jul 28, 2026. The device falls under product code SIU (Predictive Indicator For Long-Term Cardiovascular Outcomes), a Class II device regulated under 21 CFR 870.2215. Caristo Diagnostics , Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Jul 28, 2026
- Date Received
- Sep 4, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Predictive Indicator For Long-Term Cardiovascular Outcomes
- Device Class
- Class II
- Regulation Number
- 870.2215
- Review Panel
- CV
- Submission Type
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.