MVision Segmentation Service

Organization name

MVision AI Oy

SRN

FI-MF-000013082

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW011

  WARNING – A system or process must ensure that the delineations are reviewed and approved by a radiation therapy professional before possible diagnostic or therapeutic use.CAUTION – The user is responsible for managing risk related to custom ROI names in their workflow. Special attention should be paid to ROI names that suggest target volumes. CAUTION – US Federal law restricts the device to be sold on the basis of a physician prescription.

Primary placement in Finland; available across 21 countries total.

Trade name

MVision Segmentation Service

UDI-DI code

06429830064206

Basic UDI-DI

B-06429830064206

Reference / catalog number

06429830064206

Issuing entity

GS1

Risk category

Class I

Applicable legislation

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

Minor version upgrade (v1.2.7) of MVision AI Segmentation 1.2 : - New auto-segmentation models for the EU market: CT Brachy Cervix CT Mediastinum LN CT Rectum LN - New version of an existing auto-segmentation model for the EU market: CT Male Pelvis B - Better support for large scans - Multi-user support: Customization and licenses can be shared - ESAPI Plugin - Config UI & Contour+ web: Usability improvement - update dependencies Note : No impact on existing indication of use , No significant changes to the design, No impacts on performance or established safety / hazards of the product with this minor version of the product.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Z11010292INSTRUMENTS FOR RADIOTHERAPY SIMULATION - MEDICAL DEVICE SOFTWARE

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification