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WorkstationOne

by Three Palm Software 3 variants

Ref 1.9.1

WorkstationOne (1.9.1) is a device classified as Class I in the EU and Class II in the US made by Three Palm Software, registered in EUDAMED on 22 Jul 2022 (Basic UDI-DI ++B148WSONE1919U), cleared under FDA 510(k) K073272 on 11 Dec 2007 and listed in FDA GUDID since 22 Jul 2022 (UDI-DI B148WSONE1910), active as of 22 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 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K073272

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B148WSONE1919U Basic UDI-DI B148WSONE1910UDI-DIDate22 Jul 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberB148WSONE1910 UDI-DI Date22 Jul 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK073272 Date11 Dec 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI ++B148WSONE1919U registered 22 Jul 2022 Active
  • FDA 510(k) K073272 decided 11 Dec 2007 Active
  • FDA GUDID UDI-DI B148WSONE1910 listed 22 Jul 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K073272
  2. Registered EUDAMED ++B148WSONE1919U
  3. Listed FDA GUDID B148WSONE1910

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  • Withdrawn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

Generic name
Radiology picture archiving and communication system workstation
Model / reference
1.9.1
Primary DI / UDI-DI
B148WSONE1910
Basic UDI-DI
++B148WSONE1919U
Direct marketing DI
B148WSONE1910
510(k) Number
FDA product code
LLZ
EMDN code
Z11069005 Diagnostic imaging workstations
GMDN term
Radiology picture archiving and communication system workstation
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.2050
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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
US-MF-000002924
Authorised representative
Wellkang Ltd XI-AR-000001836

Related devices

Category: Tissue specimen x-ray system IVD

Similar devices in this category

Other devices filed under DIAGNOSTIC IMAGING WORKSTATIONS.

Other devices from Three Palm Software

See all devices from Three Palm Software →

Properties

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