FDA.reportPublic FDA data

AlignRT 7.3 (software)

Primary DI
05056190500726
Brand
AlignRT 7.3 (software)
Company
VISION RT LIMITED
Model
AlignRT 7.3 (software)
Catalog number
AlignRT 7.3 (software)
Device description
AlignRT 7.3 (software) used on AlignRT Plus systems
Published
2024-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K233622000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233622000AlignRT PlusVision Rt, Ltd.2024-03-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056190500726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056190500726050561905007265056190500726

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

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
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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