ARTAssistant

Primary DI
06973127400135
Brand
ARTAssistant
Company
Manteia Technologies Co.,Ltd.
Model
1.1
Device description
ARTAssistant, is a standalone software which is positioned as an adaptive radiotherapy auxiliary system, aiming to provide a complete solution to assist the implementation ofadaptive radiotherapy, helping hospitals to implement adaptive radiotherapy on ordinary image-guided accelerators based on the current situation. This system is mainly used to assist in the image processing of online adaptive radiotherapy, thereby helping users complete the design of the daily adaptive radiotherapy plan based on the processed images.
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250780000ARTAssistantManteia Technologies Co., Ltd.2025-12-05QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973127400135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973127400135069731274001356973127400135

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Regulatory Flags#

DUNS number
416535464
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973127400098AccuContour4.02026-04-27
06973127400111AccuCheck1.22026-04-22
06973127400029AccuContourAccuContour2025-06-16
06973127400012AccuContour1.1.02020-06-22
06973127400050AccuContour3.1.02023-04-01
06973127400043AccuCheck1.12023-11-06
06973127400067MOZI TPS1.32023-11-06
16973127400019AccuContour1.1.02020-06-22

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Primary DI, Brand, Company table
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