Eu Mdr Eu Md Class 2a On The Market ๐Ÿ‡ซ๐Ÿ‡ฎ Finland

Contour+ (MVision AI Segmentation)

MVision AI Oy ยท ๐Ÿ‡ซ๐Ÿ‡ฎ Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
15
Notified Bodies
0

Basic Information

Primary DI
06429830064206
Basic UDI-DI Code
64298300642AISEG1.2SZ
Reference
Contour+ (MVision AI Segmentation)
Device Types
None provided
Regulation
Eu Mdr
Classification
Eu Md Class 2a
Status
On The Market
Manufacturer
MVision AI Oy

Additional Description

Contour+ (MVision AI Segmentation) is a software system for image analysis algorithms to be used in radiation therapy treatment planning workflows. The system includes processing tools for automatic contouring of CT and MR images using machine learning based algorithms. The produced segmentation templates for regions of interest must be transferred to appropriate image visualisation systems as an initial template for a medical professional to visualize, review, modify and approve prior to further use in clinical workflows. The system creates initial contours of pre-defined structures of 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.

CND Nomenclature Codes

Code Description
Z11010292 INSTRUMENTS FOR RADIOTHERAPY SIMULATION - MEDICAL DEVICE SOFTWARE

Available In Countries

๐Ÿ‡ฉ๐Ÿ‡ช Germany ๐Ÿ‡ฉ๐Ÿ‡ฐ Denmark ๐Ÿ‡ช๐Ÿ‡ช Estonia ๐Ÿ‡ฌ๐Ÿ‡ท Greece ๐Ÿ‡ช๐Ÿ‡ธ Spain ๐Ÿ‡ซ๐Ÿ‡ฎ Finland ๐Ÿ‡ซ๐Ÿ‡ท France ๐Ÿ‡ญ๐Ÿ‡บ Hungary ๐Ÿ‡ฎ๐Ÿ‡ช Ireland ๐Ÿ‡ฎ๐Ÿ‡ธ Iceland ๐Ÿ‡ฎ๐Ÿ‡น Italy ๐Ÿ‡ต๐Ÿ‡น Portugal ๐Ÿ‡ท๐Ÿ‡ด Romania ๐Ÿ‡ธ๐Ÿ‡ช Sweden ๐Ÿ‡ฌ๐Ÿ‡ง United Kingdom

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