AlignRT Plus Workstation Z4 - IGB GEN ART
AlignRT Plus Workstation Z4 - IGB GEN ART is a Class II device made by Vision RT Limited, cleared under FDA 510(k) K203387 on 4 Mar 2021 and listed in FDA GUDID since 23 Sep 2021 (UDI-DI 05056190500238), 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 | Number05056190500238 | Date23 Sep 2021 | StatusListed |
| United States | FDA 510(k) | NumberK203387 | Date4 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 05056190500238
- FDA 510(k) database K203387
Across registries
- FDA 510(k) K203387 decided 4 Mar 2021 Active
- FDA GUDID UDI-DI 05056190500238 listed 23 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K203387
- Listed FDA GUDID 05056190500238
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- AlignRT Plus
- Generic name
- Radiological video camera patient positioning/tracking system
- Model / reference
- Workstation Z4 - IGB GEN ART
- Primary DI / UDI-DI
- 05056190500238
- 510(k) Number
- FDA product code
- IYE
- GMDN term
- Radiological video camera patient positioning/tracking system
- Device class
- Class II
- Regulation number
- 892.5050
- GUDID distribution status
- In Commercial Distribution
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