FDA.reportPublic FDA data

AlignRT Plus

Primary DI
05056190500665
Brand
AlignRT Plus
Company
VISION RT LIMITED
Model
Fujitsu M7010X
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
K203387000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203387000AlignRT PlusVision Rt, Ltd.2021-03-04IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056190500665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056190500665050561905006655056190500665

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
00840277411815Gold MarkerRIVERPOINT MEDICAL, LLCIYE2026-03-11
00850002461343BiomarC®Carbon Medical Technologies, Inc.IYE2024-07-23
00850002461350Carbon Bright ®Carbon Medical Technologies, Inc.IYE2024-07-23
00850016008176VeraFormViscus Biologics LLCIYE2024-01-16
07340145700421Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700445Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700506Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700582Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700643Gold AnchorNaslund Medical ABIYE2023-01-23
07340145700667Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701060Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701084Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701107Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701121Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701145Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701169Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701183Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701206Gold AnchorNaslund Medical ABIYE2023-01-23
07340145701220Gold AnchorNaslund Medical ABIYE2023-01-23
B887001062X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B887001067X-MARK UltraIzi Medical Products, LLCIYE2022-07-18
B8870010010X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010020X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010030X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010070X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010080X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010090X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010210X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010220X-MARKIzi Medical Products, LLCIYE2022-06-17
B8870010230X-MARKIzi Medical Products, LLCIYE2022-06-17