EchoNext— 510(k) K260332
Substantially EquivalentPathwai, Inc.
FDA 510(k) clearance K260332 for EchoNext, Substantially Equivalent on 2026-06-08. Applicant: Pathwai, Inc.. Device class: 2.
Clearance details
- Applicant
- Pathwai, Inc.
- Product code
- Code QXO
- Device class
- Class 2
- Regulation
- 21 CFR 870.2380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
Recent devices under product code QXO
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