SIU — Predictive Indicator For Long-Term Cardiovascular Outcomes Class II
FDA product code SIU covers "Predictive Indicator For Long-Term Cardiovascular Outcomes", a Class II medical device regulated under 21 CFR 870.2215. Submissions are reviewed by the Cardiovascular panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SIU
- Device Class
- Class II
- Regulation Number
- 870.2215
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250042 | Caristo Diagnostics | CaRi-Heart | Jul 28, 2026 |