Viz LVO 1.6
by Viz.ai
Viz LVO 1.6 is a Class II device made by Viz.ai, granted FDA De Novo DEN170073 on 13 Feb 2018 and listed in FDA GUDID since 2 Jul 2019 (UDI-DI 00811852030080), active (FDA De Novo), not in commercial distribution (GUDID) as of 22 Oct 2026.
Active
De Novo
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00811852030080 | Date2 Jul 2019 | StatusListed |
| United States | FDA De NovoDENG | NumberDEN170073 | Date13 Feb 2018 | StatusActive |
Official records
- AccessGUDID record 00811852030080
- FDA De Novo database DEN170073
Across registries
- FDA De Novo DEN170073 decided 13 Feb 2018 Active
- FDA GUDID UDI-DI 00811852030080 listed 2 Jul 2019 Listed
Timeline
- Granted FDA De Novo DEN170073
- Listed FDA GUDID 00811852030080
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- Trade name
- Viz LVO
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.6
- Primary DI / UDI-DI
- 00811852030080
- De Novo Number
- FDA product code
- QAS
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2080
- GUDID distribution status
- Not in Commercial Distribution
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