EchoNext
FDA 510(k) clearance K260332 · decided 2026-06-08
Clearance details
- K-number
- K260332
- Device name
- EchoNext
- Applicant
- Pathwai, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-02
- Decision date
- 2026-06-08
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- QXO
- Device class
- 2
- Regulation number
- 870.2380
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- New York, NY, 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 |
|---|---|---|
| Viz HCM (DEN230003) | Viz. Ai, Inc. | 2023-08-03 |
Recalls involving this device
No recalls on record reference this clearance.