AlignRT Plus Workstation Z4 - IGB CS ART
AlignRT Plus Workstation Z4 - IGB CS 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 05056190500221), 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 | Number05056190500221 | Date23 Sep 2021 | StatusListed |
| United States | FDA 510(k) | NumberK203387 | Date4 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 05056190500221
- FDA 510(k) database K203387
Across registries
- FDA 510(k) K203387 decided 4 Mar 2021 Active
- FDA GUDID UDI-DI 05056190500221 listed 23 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K203387
- Listed FDA GUDID 05056190500221
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- Withdrawn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 CS ART
- Primary DI / UDI-DI
- 05056190500221
- 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
Similar devices
Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).
- Med-Tec Breast Support System by Medtec LLC
- KLARITY MEDICAL R550-U4 by Klarity Medical Products, LLC
- FiberVision by Fiber Imaging, Inc.
- PRONEX Linear Accelerator by Direx Systems Corp.
- Quality Reports by Sun Nuclear Corporation
- KLARITY MEDICAL R550-LB1 by Klarity Medical Products, LLC
- Dynatrac, Cod. 50-1A by 3D Line USA, Inc.
- MAPCHECK2, ARCCHECK by Sun Nuclear Corporation
- ThinkQA Edition 2 2.0.0 TK2010, TK2020 by DOSISOFT
- IMSure Brachy QA Software, Model 91331 by STANDARD IMAGING INC.