510(k) K260332
- Device
- EchoNext
- Applicant
- Pathwai, Inc.
- 510(k) number
- K260332
- Product code
- QXO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-06-08
- Date received
- 2026-02-02
- Regulation
- 870.2380
- Classification name
- Cardiovascular Machine Learning-Based Notification Software
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Pierre Elias
- Address
- 189 W 89th St. Apt. 6e New York NY US 10024 10024
FDA Registration Numbers#
- 3014665798
- 3014678441
Source Documents#
Other 510(k) Records For Product Code QXO#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023-08-03 |