FDA Product Code
FDA Product Code QXO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.2380
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K260332 | EchoNext | Pathwai, Inc. | 2026-06-08 | Traditional | PDF ↗ |
| DEN230003 | Viz HCM | Viz. Ai, Inc. | 2023-08-03 | Direct | — |
Product code QXO · Class II · Cardiovascular. Data: openFDA.