510(k) K251293
K251293 is an FDA 510(k) premarket notification submitted by Icardio.Ai for the device "CardioVision". The FDA issued a decision of Substantially Equivalent on Nov 21, 2025. The device falls under product code QUO (Adjunctive Heart Failure Status Indicator), a Class II device regulated under 21 CFR 870.2200. Icardio.Ai has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 21, 2025
- Date Received
- Apr 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adjunctive Heart Failure Status Indicator
- Device Class
- Class II
- Regulation Number
- 870.2200
- Review Panel
- CV
- Submission Type
The adjunctive heart failure status indicator is a prescription device based on sensor technology or image data to provide information to an interpreting clinician in detecting heart failure. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.