Viz HCM
by Viz.ai, Inc.
De Novo DEN230003
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN230003 | Date3 Aug 2023 | StatusActive |
Official records
- FDA De Novo database DEN230003
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA product code
- QXO
- FDA applicant
- Viz. Ai, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.2380
- Advisory committee
- Cardiovascular
- FDA decision
- DENG De Novo granted
Overview
AI-generated summary, 12 Nov 2026
Viz HCM is a cardiovascular machine learning-based notification software.
It received De Novo authorization under DEN230003 on 2023-08-03 as a Class II device with product code QXO under regulation 870.2380.
Devices cleared under DEN230003
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Viz HCM Software | Viz HCM Software | 00811852030332 | — | On the market |