AlignRT 7.3 (software) AlignRT 7.3 (software)

GUDID 05056190500726

AlignRT 7.3 (software) used on AlignRT Plus systems

VISION RT LIMITED

Radiological video camera patient positioning/tracking system
Primary Device ID05056190500726
NIH Device Record Key13eab28e-1605-4ce3-afd9-59dcdfe5af58
Commercial Distribution StatusIn Commercial Distribution
Brand NameAlignRT 7.3 (software)
Version Model NumberAlignRT 7.3 (software)
Catalog NumberAlignRT 7.3 (software)
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105056190500726 [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 Date2024-04-11
Device Publish Date2024-04-03

Devices Manufactured by VISION RT LIMITED

05056190500658 - SafeID2025-12-31 SafeID 2.0
05056190500924 - MapRT2025-12-31 MapRT system
05056190500931 - AlignRT Plus2025-12-31 Horizon camera (close range)
05056190501037 - AlignRT Plus2025-12-31 Real Time Coach MK2
05056190501044 - MapRT2025-12-31 MapRT Mapping application (v1.2)
05056190501051 - MapRT2025-12-31 MapRT Capture (v1.2)
05056190501068 - AlignRT Plus2025-12-31 InBore Fibre Hub
05056190501099 - MapRT2025-12-31 MapRT couch markers

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