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Corridor4DM C4DM10

by Invia

Ref Corridor4DMModel Corridor4DM v2018; Corridor4DM v2023; Corridor4DM v2024; Corridor4DM v2025, Corridor4DM v2017; Corridor4DM v2018; Corridor4DM v2023; Corridor4DM v2024; Corridor4DM v2025

Corridor4DM C4DM10 is a medical device (EU MDD Class IIa; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological; EMDN category various instruments for nuclear medicine - medical device software) made by Invia, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 08649740002C4DM10SR), cleared under FDA 510(k) K101279 on 4 Aug 2010 and listed in FDA GUDID since 1 Sep 2018 (UDI-DI 00864974000257), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K101279

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number08649740002C4DM10SR Basic UDI-DI 00864974000257UDI-DIDate1 Jun 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number08649740002C4DM10SR Basic UDI-DI 00864974000257UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00864974000257 UDI-DI Date1 Sep 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK101279 Date4 Aug 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08649740002C4DM10SR registered 1 Jun 2026 Active· +1 more in the status table
  • FDA 510(k) K101279 decided 4 Aug 2010 Active
  • FDA GUDID UDI-DI 00864974000257 listed 1 Sep 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K101279
  2. Listed FDA GUDID 00864974000257
  3. Registered EUDAMED 08649740002C4DM10SR

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Corridor4DM
Generic name
Radiology DICOM image processing application software
Model / reference
Corridor4DM v2018 EUDAMED
Corridor4DM v2023 EUDAMED
Corridor4DM v2024 EUDAMED
Corridor4DM v2025 EUDAMED
Corridor4DM EUDAMED
Corridor4DM v2017 EUDAMED
C4DM10 GUDID
Primary DI / UDI-DI
00864974000257
Basic UDI-DI
08649740002C4DM10SR, B-00864974000257
Direct marketing DI
00864974000257
510(k) Number
FDA product code
LLZ
EMDN code
Z11029092 Various instruments for nuclear medicine - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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: Radiology DICOM image processing application software

Cleared under the same submission (K101279)

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - MEDICAL DEVICE SOFTWARE.

Other devices from Invia

  • 4DM

    Class II

  • Corridor4DM v2016

    Class II

  • Corridor4DM v2017

    Class II

  • CORRIDOR4DM

    Class II

See all devices from Invia →

Properties

  • Measuring function
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)