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MVision Segmentation Service

by MVision AI Oy Finland EUDAMED510(k)GUDID

Ref 06429830064206, Contour+ (MVision AI Segmentation)Model 1.2/1.2.1, Contour+ (MVision AI Segmentation) 1.2510(k) K241490

Product code QKBEMDN Z11010292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06429830064206 UDI-DIDate31 Dec 2024ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK241490 Date18 Oct 2024ClearedStatusActive
European UnionCE/MDR EUDAMED NumberB-06429830064206 Basic UDI-DIDate26 Nov 2021RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-06429830064206 Basic UDI-DIDate26 Nov 2021RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR, CE/MDD Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Trade Name
MVision Segmentation Service EUDAMED
Contour+ (MVision AI Segmentation) EUDAMEDGUDID
Generic Name
Image segmentation application software
Device Name
MVision Segmentation Service
Model / Reference
1.2/1.2.1 EUDAMED
06429830064206 EUDAMED
Contour+ (MVision AI Segmentation) 1.2 EUDAMED
Contour+ (MVision AI Segmentation) EUDAMED
1.2 GUDID
Primary DI / UDI-DI
06429830064206
Basic UDI-DI
B-06429830064206, 64298300642AISEG1.2SZ
Direct Marketing DI
06429830064206
510(k) Number
FDA Product Code
QKB
EMDN Code
Z11010292 Instruments for radiotherapy simulation - medical device software
GMDN Term
Image segmentation application software
Device Class
Class I EUDAMED
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
-1192
Software
Market of Registration
Finland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
1.2/1.2.1
06429830064206
Contour+ (MVision AI Segmentation) 1.2
Contour+ (MVision AI Segmentation)
GUDID
1.2
Device ClassEUDAMED
Class I
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000013082

Other devices from Mvision AI Oy

  • Workspace+

    Class IIa

  • Dose+

    Class IIa

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Manufacturing Date
Other properties (22)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No

Sources (4)

  • EUDAMED e0aa99ed-6215-4127-b896-8164b72fa0a0 85 fields · synced 22 Oct 2026
  • EUDAMED 06429830064206|64298300642AISEG1.2SZ 61 fields · synced 18 May 2026
  • FDA UDI 5eecd037-8585-4468-b0dd-93736a4a4e89 34 fields · synced 30 May 2026
  • FDA 510(k) K241490 1 fields · synced 18 May 2026