FDA.reportPublic FDA data

AlignRT Plus

Primary DI
05056190500016
Brand
AlignRT Plus
Company
VISION RT LIMITED
Model
GateRT
Published
2021-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
05056190500016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056190500016050561905000165056190500016

GMDN Terms#

Term, Definition table
TermDefinition
Radiological video camera patient positioning/tracking systemAn assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
222160801
Device count
1
Serial number
true
Manufacturing date on label
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21