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Veolity

by MeVis Medical Solutions AG

Ref Veo-2200Model 2.x

Veolity (Veo-2200) is a medical device (EU MDR Class IIa; FDA Class II; EMDN category computed tomographs (ct) - software accessories) made by Mevis Medical Solutions AG, registered in EUDAMED on 25 Jan 2023 (Basic UDI-DI 0426048329VEO35), cleared under FDA 510(k) K201501 on 23 Feb 2021 and listed in FDA GUDID since 9 Jan 2025 (UDI-DI 04260483290244), active as of 23 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201501↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04260483290244 UDI-DI Date9 Jan 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number0426048329VEO35 Basic UDI-DI 04260483290244UDI-DIDate25 Jan 2023RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK201501 Date23 Feb 2021IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0426048329VEO35 registered 25 Jan 2023 Active
  • FDA 510(k) K201501 decided 23 Feb 2021 Active
  • FDA GUDID UDI-DI 04260483290244 listed 9 Jan 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201501
  2. Registered EUDAMED 0426048329VEO35
  3. Listed FDA GUDID 04260483290244

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k) · GUDID

Generic name
Radiology DICOM image processing application software
Model / reference
2.x EUDAMED
Veo-2200 EUDAMED
2.2 GUDID
Primary DI / UDI-DI
04260483290244
Basic UDI-DI
0426048329VEO35
Direct marketing DI
04260483290244
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
Special device type
Software
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
2.x
Veo-2200
GUDID
2.2
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.

Manufacturer details

EUDAMED SRN
DE-MF-000005418

Related devices

Category: Full-body CT system

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

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)