AccuContour

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…

Registry build 21.09.26

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 contouring It 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.

2manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Fujian (1), Beijing (1).

Chinese manufacturers registered for FDA product code QKB
Manufacturer City Province Registered as Device types
Manteia Technologies Co., Ltd. Xiamen Fujian Manufacturer 3
Medmind Technology Co., Ltd. Beijing Beijing Manufacturer 1

Record

Regulatory record for AccuContour
Listed by Manteia Technologies Co., Ltd., China
FDA product code QKB
Device type Radiological Image Processing Software For Radiation Therapy
Device class Class 2
Regulation 21 CFR 892.2050
Establishment Manufacturer
510(k) K221706
Record published 2023-04-01
Record revised 2023-12-04 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, serial number
Packaging Box
Distribution end date 2025-06-16
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for AccuContour
Catalogue number Size Status
3.1.0 In distribution
4.0 In distribution
1.1.0 In distribution
AccuContour Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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ART-Plan Therapanacea 3
AutoContour Radformation, Inc. 2
DeepContour Wisdom Medical Technologies 1
ContourProtégéAI – CT Abdomen MIM Software Inc. 1
VBrain Vysioneer, Inc. 1
ContourProtégéAI – MR Prostate MIM Software Inc. 1
RT-Mind-AI Medmind Technology Co., Ltd. 1
MRI Planner Spectronic Medical AB 1
ContourProtégéAI – CT Prostate MIM Software Inc. 1
Aview RT ACS Coreline Soft Co., Ltd. 1

Showing 12 of 25. All products under Radiological Image Processing Software For Radiation Therapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K251351 2026-01-23
K250780 2025-12-05
K221706 2023-03-09

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer