Contour+ (MVision AI Segmentation)

Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment…

Registry build 21.09.26

Contour+ (MVision AI Segmentation) provides a software interface to image analysis algorithms to be used in clinical workflows including, but not limited to, radiation therapy treatment planning workflows. The system includes processing tools for automatically contouring of imaging data of supported modalities CT and MRI using machine learning based algorithms. The produced segmentation templates for regions of interest are intended to be transferred to appropriate image visualization systems to be used as a template for a medical professional to visualize, modify and approve prior to further use in clinical workflows. The system supports automatic contouring of pre-defined structures from common anatomical sites, i.e. Head and Neck, Brain, Breast, Lung and Abdomen, Male Pelvis, and Female Pelvis. Contour+ (MVision AI Segmentation) is not intended to detect lesions or tumors. The device is not intended for use with real-time adaptive planning workflows.

2manufacturers in China registered for this device type
1catalogue number
2510(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 Contour+ (MVision AI Segmentation)
Listed by Mvision AI Oy, Finland
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) K241490
Record published 2024-12-31

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Latex Labelled latex-free
Label carries manufacturing date

Catalogue Numbers

Catalogue numbers for Contour+ (MVision AI Segmentation)
Catalogue number Size Status
1.2 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AI-Rad Companion Organs RT Siemens Healthcare Limited 6
AccuContour Manteia Technologies Co., Ltd. 4
ContourProtégéAI MIM Software Inc. 3
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

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
K241490 2024-10-18
K212915 2022-05-03

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