FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EchoNext
K Number: K260332
·
Decision Jun 8, 2026
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
1
Review Days
126
Basic Information
- Device Name
- EchoNext
- K Number
- K260332
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pathwai, Inc.
- Date Received
- February 2, 2026
- Decision Date
- June 8, 2026
- Product Code
- QXO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QXO | Cardiovascular Machine Learning-Based Notification Software | FDA class 2 | Cardiovascular |
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