AccuContour

Primary DI
06973127400098
Brand
AccuContour
Company
Manteia Technologies Co.,Ltd.
Model
4.0
Device description
It is used by oncology department to register multi-modality images and segment (non-contrast) CT images, to generate needed information for treatment planning, treatment evaluation and treatment adaptation. The product has two image processing functions:(1) Deep learning contouring: it can automatically contour organs-at-risk, in head and neck,thorax, abdomen and pelvis (for both male and female) areas,(2) Automatic registration: rigid and deformable registration, and(3) Manual contouringIt also has the following general functions:Receive, add/edit/delete, transmit, input/export, medical images and DICOM data;Patient management;Review tool of processed images;Extension tool;Plan evaluation and plan comparison;Dose analysis.
Published
2026-04-27
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
K251351000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251351000AccuContour 4.0Manteia Technologies Co., Ltd.2026-01-23QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973127400098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973127400098069731274000986973127400098

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
06973127400111AccuCheck1.22026-04-22
06973127400135ARTAssistant1.12026-04-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809839660001OncoStudioOncoSoft. co.,Ltd.QKB2026-05-08
00860015780805INTContourCarina Medical LLCQKB2026-04-27
00860010267103DeepContourWisdom Technologies, IncQKB2026-04-22
06973127400135ARTAssistantManteia Technologies Co.,Ltd.QKB2026-04-22
00850009343345ContourProtégéAIMIM SOFTWARE INC.QKB2026-04-07
00850072631042AutoContourRadformation, IncQKB2026-03-30
00860009223660Neosoma Brain MetsNeosoma, Inc.QKB2026-02-10
00198953043387MR Contour DLGE HEALTHCAREQKB2026-01-23
03770019940013ART-PlanTHERAPANACEAQKB2025-12-10
03770019940020ART-PlanTHERAPANACEAQKB2025-12-10
06973127400029AccuContourManteia Technologies Co.,Ltd.QKB2025-06-16
04068151010404AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-06-05
04056869973371AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-04-30
00628011382184Limbus ContourLimbus Ai Inc.QKB2025-02-19
06429830064206Contour+ (MVision AI Segmentation) Mvision AI OyQKB2024-12-31
00195278560384Auto SegmentationGE Medical Systems, L.L.C.QKB2024-11-05
00850009343307ContourProtégéAIMIM SOFTWARE INC.QKB2024-03-20
00850009343291ContourProtégéAIMIM SOFTWARE INC.QKB2023-08-20
04719884900011VBrainVysioneer Inc.QKB2023-08-08
06973127400050AccuContourManteia Technologies Co.,Ltd.QKB2023-04-01
07350097430017MRI PlannerSpectronic Medical ABQKB2023-01-31
08800025300145AVIEW RT ACSCORELINE SOFT CO.,LTD.QKB2022-11-30
04056869955667AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2022-11-09
03770019940006ART-PlanTHERAPANACEAQKB2022-10-26
00850009343178ContourProtégéAI - CT AbdomenMIM SOFTWARE INC.QKB2022-05-16
00850009343215ContourProtégéAI - CT Lung and LiverMIM SOFTWARE INC.QKB2022-05-16
00850009343239ContourProtégéAI - CT SurePlan MRTMIM SOFTWARE INC.QKB2022-05-16
06975191150008RT-Mind-AIMedMind Technology Co., Ltd.QKB2022-03-15
07340201500040AATMAElekta Solutions ABQKB2022-03-09
00860001672732AutoContourRadformation, IncQKB2021-10-11