K260332
- 510(k) number
- K260332
- Device name
- EchoNext
- Applicant
- Pathwai, Inc. NY · US
- Product code
- QXO — Cardiovascular Machine Learning-Based Notification S
- Decision date
- 2026-06-08
- Date received
- 2026-02-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K260332.pdf
Official FDA record: K260332
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.