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Veolity 1.7

by MeVis Medical Solutions AG

Ref Veo-17xxModel 1.7.x

Veolity 1.7 is a medical device (EU MDD Class IIa; FDA Class II; EMDN category computed tomographs (ct) - software accessories) made by MeVis Medical Solutions AG, registered in EUDAMED on 31 Aug 2026 (Basic UDI-DI B-04260483290176), cleared under FDA 510(k) K201501 on 23 Feb 2021 and listed in FDA GUDID since 18 Mar 2021 (UDI-DI 04260483290176), 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) K201501

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 NumberB-04260483290176 Basic UDI-DI 04260483290176UDI-DIDate31 Aug 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED NumberB-04260483290176 Basic UDI-DI 04260483290176UDI-DIDate31 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260483290176 UDI-DI Date18 Mar 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK201501 Date23 Feb 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04260483290176 registered 31 Aug 2026 Active· +1 more in the status table
  • FDA 510(k) K201501 decided 23 Feb 2021 Active
  • FDA GUDID UDI-DI 04260483290176 listed 18 Mar 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201501
  2. Listed FDA GUDID 04260483290176
  3. Registered EUDAMED B-04260483290176

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  • Withdrawn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
Veolity
Generic name
Radiology DICOM image processing application software
Model / reference
1.7.x EUDAMED
Veo-17xx EUDAMED
1.7 GUDID
Description
1.7.0.228241, Release date: 2021-03-18 1.7.1.252491, Release date: 2022-03-25
Primary DI / UDI-DI
04260483290176
Basic UDI-DI
B-04260483290176
510(k) Number
FDA product code
OEB, LLZ
EMDN code
Z11030682 Computed tomographs (CT) - software accessories
GMDN term
Radiology DICOM image processing application 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
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1.7.x
Veo-17xx
GUDID
1.7
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

Similar devices in this category

Other devices filed under COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES.

Other devices from MeVis Medical Solutions AG

See all devices from MeVis Medical Solutions AG →

Properties

  • Measuring function
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)