AlignRT Plus

GUDID 05056190500641

VISION RT LIMITED

Radiological video camera patient positioning/tracking system

• Primary Device ID: 05056190500641
• NIH Device Record Key: 4a12a0b4-7a39-4309-93d7-c85637dcd03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AlignRT Plus
• Version Model Number: AlignRT InBore 7.0
• Company DUNS: 222160801
• Company Name: VISION RT LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com
• Phone: +1 866 594 5443
• Email: info@visionrt.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05056190500641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203387

FDA Product Code

• IYE: Accelerator, Linear, Medical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-01
• Device Publish Date: 2021-09-23

On-Brand Devices [AlignRT Plus]

• 05056190500719: Calibration Plate Narrow
• 05056190500696: Calibration Plate
• 05056190500665: Fujitsu M7010X
• 05056190500641: AlignRT InBore 7.0
• 05056190500627: Patient Data Workstation Z2T
• 05056190500610: AlignRT Offline Z2T
• 05056190500566: Lenovo P340 workstation
• 05056190500559: AlignRT InBore 6.4
• 05056190500542: InBore Power Repeater
• 05056190500535: InBore System Cabinet
• 05056190500528: InBore 60mm Calibration Plate Riser
• 05056190500511: InBore Patient Imaging Assembly
• 05056190500481: AlignRT 6.3
• 05056190500443: AlignRT InBore
• 05056190500436: Workstation Z2
• 05056190500351: OSMS 6.2 - 115V
• 05056190500344: AlignRT
• 05056190500337: AlignRT Plus 6.2 - 115V & 230V
• 05056190500320: AlignRT Plus 6.1 - 115V & 230V
• 05056190500313: Patient Data Workstation
• 05056190500306: MMI 1.0 Breakout Box
• 05056190500276: ART Remote Control
• 05056190500269: OSMS Remote Control
• 05056190500252: Workstation Z4 - IGC Gen GCT
• 05056190500245: Workstation Z4 - ART
• 05056190500238: Workstation Z4 - IGB GEN ART
• 05056190500221: Workstation Z4 - IGB CS ART
• 05056190500207: Workstation Z4 - OSMS CS
• 05056190500191: Workstation Z4 - OSMS TB
• 05056190500184: HD CAM Gen 5
• 05056190500177: AlignRT 6.0 - 115V & 230V
• 05056190500153: OSMS 5.1 - TB 115V
• 05056190500122: OSMS 5.1 115V
• 05056190500115: OSMS 5.0 - TB 115V
• 05056190500092: Remote Control
• 05056190500085: OSMS 5.0
• 05056190500078: HD CAM
• 05056190500061: Power Supply Unit (PSU)
• 05056190500054: Real Time Coach
• 05056190500047: Head Adjuster
• 05056190500030: AlignRT Offline
• 05056190500023: GateCT
• 05056190500016: GateRT
• 05056190500009: AlignRT 5.0
• 05056190500689: Horizon camera pod
• 05056190500672: Touchless4D version 7.2
• 05056190500597: SimRT version 7.2
• 05056190500580: SimRT system, version 7.2
• 05056190500795: Varian ProBeam Hold - Switch Box
• 05056190500788: Real Time Coach