CardioVision
FDA 510(k) clearance K251293 · decided 2025-11-21
Clearance details
- K-number
- K251293
- Device name
- CardioVision
- Applicant
- Icardio.Ai
- Decision
- Substantially Equivalent
- Date received
- 2025-04-25
- Decision date
- 2025-11-21
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- QUO
- Device class
- 2
- Regulation number
- 870.2200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Hollywood, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EchoGo Heart Failure (2.0) (K240013) | Ultromics Limited | 2024-09-23 |
| Vivio® LVEDP System (K223905) | Avicena, LLC | 2023-10-06 |
| EchoGo Heart Failure (K222463) | Ultromics Limited | 2022-11-23 |
Recalls involving this device
No recalls on record reference this clearance.