Visix 2.3.9
Visix 2.3.9 is a Class II device made by Televere Systems, cleared under FDA 510(k) K082623 on 25 Feb 2009 and listed in FDA GUDID since 27 Sep 2016 (UDI-DI 00851800007030), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00851800007030 | Date27 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK082623 | Date25 Feb 2009 | StatusActive |
Official records
- AccessGUDID record 00851800007030
- FDA 510(k) database K082623
Across registries
- FDA 510(k) K082623 decided 25 Feb 2009 Active
- FDA GUDID UDI-DI 00851800007030 listed 27 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K082623
- Listed FDA GUDID 00851800007030
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Visix
- Generic name
- Radiological PACS-dedicated management software
- Model / Ref / Catalog
- 2.3.9, Visix 2.3.9
- Primary DI / UDI-DI
- 00851800007030
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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