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ContourProtégéAI 1.3

by Mim Software Inc.

Ref 6012418

ContourProtégéAI 1.3 is a radiological PACS-dedicated management software (EU MDD Class IIa; FDA Class II; FDA product code QKB, Radiological Image Processing Software For Radiation Therapy) made by Mim Software Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI B-00850009343307) and listed in FDA GUDID since 20 Mar 2024 (UDI-DI 00850009343307), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00850009343307 Basic UDI-DI 00850009343307UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850009343307 UDI-DI Date20 Mar 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00850009343307 registered 11 Jun 2026 Active
  • FDA GUDID UDI-DI 00850009343307 listed 20 Mar 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850009343307
  2. Registered EUDAMED B-00850009343307

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Contour ProtégéAI+ EUDAMED
ContourProtégéAI GUDID
Generic name
Radiological PACS-dedicated management software
Model / reference
6012418 EUDAMED
1.3 GUDID
Primary DI / UDI-DI
00850009343307
Basic UDI-DI
B-00850009343307
FDA product code
QKB
EMDN code
Z110603 Picture archiving and communication systems
GMDN term
Radiological PACS-dedicated management software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
EU registration type
Legacy device (under a directive)
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
6012418
GUDID
1.3
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radiological PACS software

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Mim Software Inc.

See all devices from Mim Software Inc. →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (20, all answered No)