FDA.reportPublic FDA data

AlignRT Plus

Primary DI
05056190501211
Brand
AlignRT Plus
Company
VISION RT LIMITED
Model
8.1
Device description
AlignRT 8.1 (software)
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K253012000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253012000AlignRT Plus (8.0)Vision Rt, Ltd.2026-03-18IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056190501211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056190501211050561905012115056190501211

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.

Regulatory Flags#

DUNS number
222160801
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05056190501273MapRTHP Z2 G9 workstation - MapRT2025-12-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401443KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-24
00840510401436KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-22
00840510401412KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
00840510401429KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
00840510401382KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401399KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401405KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401375KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-22
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23