AlignRT Plus

GUDID 05056190500481

VISION RT LIMITED

Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system Radiological video camera patient positioning/tracking system
Primary Device ID05056190500481
NIH Device Record Key6e849740-8167-47c0-88b6-46582bf13608
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignRT Plus
Version Model NumberAlignRT 6.3
Company DUNS222160801
Company NameVISION RT LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com
Phone+1 866 594 5443
Emailinfo@visionrt.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105056190500481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-01
Device Publish Date2021-09-23

On-Brand Devices [AlignRT Plus]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.