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Visage Ease Pro 2.2

by Visage Imaging, Inc.

Ref VEP-2.2

Visage Ease Pro 2.2 is a device classified as Class IIa in the EU and Class II in the US made by Visage Imaging, Inc., registered in EUDAMED on 2 Apr 2026 (Basic UDI-DI 0425133292YM), cleared under FDA 510(k) K142196 on 28 Apr 2015 and listed in FDA GUDID since 29 Feb 2024 (UDI-DI 04251332920047), 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) K142196

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0425133292YM Basic UDI-DI 04251332920047UDI-DIDate2 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251332920047 UDI-DI Date29 Feb 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK142196 Date28 Apr 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0425133292YM registered 2 Apr 2026 Active
  • FDA 510(k) K142196 decided 28 Apr 2015 Active
  • FDA GUDID UDI-DI 04251332920047 listed 29 Feb 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K142196
  2. Listed FDA GUDID 04251332920047
  3. Registered EUDAMED 0425133292YM

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Visage Ease Pro
Generic name
Radiological PACS-dedicated management software
Model / reference
VEP-2.2 EUDAMED
2.2 GUDID
Primary DI / UDI-DI
04251332920047
Basic UDI-DI
0425133292YM
510(k) Number
FDA product code
LLZ
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
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
VEP-2.2
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.

Related devices

Category: Radiological PACS software

Cleared under the same submission (K142196)

Similar devices in this category

Other devices filed under PICTURE ARCHIVING AND COMMUNICATION SYSTEMS.

Other devices from Visage Imaging, Inc.

  • Visage 7 7.1.12

    Class II

  • Visage 7 7.1.10

    Class II

  • Visage 7 7.1.11

    Class II

  • Visage Ease Pro 1.8.2

    Class II

See all devices from Visage Imaging, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)