FDA.reportPublic FDA data

Vision RT

Primary DI
B120ALIGNRT0
Brand
Vision RT
Company
VISION RT LIMITED
Model
AlignRT
Catalog number
AlignRT
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123371000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123371000ALIGNRT PLUSVision RT Limited2013-01-08IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B120ALIGNRT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Video camera patient positioning/tracking systemAn assembly of hardware/software devices intended to employ stereo vision techniques to image and reconstruct three-dimensional (3-D) surfaces of a patient, projected via digital video cameras strategically configured within a treatment room which focus on the patient, to aid in the correct positioning of the patient and track events during a diagnostic imaging, treatment planning, or radiation therapy procedure. A hardware interface is used between the camera system and the CT or linear accelerator to facilitate gated capture or delivery of diagnostic or therapeutic radiation, respectively. It typically includes two or three cameras, a workstation with image display monitors and software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442083496420fsapia@visionrt.com
+1 866 594 5443info@visionrt.com

Regulatory Flags#

DUNS number
222160801
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056190501211AlignRT Plus8.12026-07-30
05056190501365AlignRTGATECT-RT 1.02026-04-27
05056190500009AlignRTAlignRT 5.x 115V or 230V2021-09-23
05056190500658SafeIDSafeID 2.02025-12-23
05056190500924MapRTMapRT system2025-12-23
05056190500931AlignRT PlusHorizon camera (close range)2025-12-23
05056190501037AlignRT PlusReal Time Coach MK22025-12-23
05056190501044MapRTMapRT Mapping application (v1.2)2025-12-23
05056190501051MapRTMapRT Capture (v1.2)2025-12-23
05056190501068AlignRT PlusInBore Fibre Hub2025-12-23
05056190501099MapRTMapRT couch markers2025-12-23
05056190501112AlignRT PlusHP Z2 G9 workstation - AlignRT2025-12-23
05056190501129AlignRT PlusHP Z2 G9 workstation - AlignRT InBore2025-12-23
05056190501150AlignRT PlusDoseRT (software phase 2)2025-12-23
05056190501167AlignRT PlusAlignRT 7.4 2025-12-23
05056190501174AlignRT PlusDoseRT (software)2025-12-23
05056190501204AlignRT PlusInBore Patient Imaging Assembly2025-12-23
05056190501242AlignRT PlusDoseRT workstation2025-12-23
05056190501259AlignRT PlusDoseRT camera-computer interface box2025-12-23
05056190501266AlignRT PlusDoseRT isolation transformer2025-12-23

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Primary DI, Brand, Company table
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00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
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B8870010230X-MARKIzi Medical Products, LLCIYE2022-06-17