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3mensio Workstation 10.4

by Pie Medical Imaging B.V.

Ref 10.4

3mensio Workstation 10.4 is a medical device (EU MDR Class IIb; FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 8056304453mensioWSZ9), cleared under FDA 510(k) K153736 on 27 May 2016 and listed in FDA GUDID since 17 Apr 2023 (UDI-DI 08056304454942), withdrawn (EUDAMED), active (FDA 510(k)) as of 23 Oct 2026. One FDA recall is linked to it.

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 Withdrawn in European Union.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

CE MDR, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K153736

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 Number8056304453mensioWSZ9 Basic UDI-DI 08056304454942UDI-DIDate15 Jun 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number08056304454942 UDI-DI Date17 Apr 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK153736 Date27 May 2016IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8056304453mensioWSZ9 registered 15 Jun 2026 Withdrawn
  • FDA 510(k) K153736 decided 27 May 2016 Active
  • FDA GUDID UDI-DI 08056304454942 listed 17 Apr 2023 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2297-2025 FDA Class II initiated 14 Jul 2025

    When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

Timeline

4 dated events

  1. Cleared FDA 510(k) K153736
  2. Listed FDA GUDID 08056304454942
  3. Recall initiated FDA recalls Z-2297-2025
  4. Registered EUDAMED 8056304453mensioWSZ9

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
3mensio Workstation
Generic name
Radiology DICOM image processing application software
Model / reference
10.4
Primary DI / UDI-DI
08056304454942
Basic UDI-DI
8056304453mensioWSZ9
Direct marketing DI
08056304454942
510(k) Number
FDA product code
LLZ
EMDN code
Z11039082 Various radiodiagnostic and interventional instruments - software accessories
GMDN term
Radiology DICOM image processing application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.2050
Special device type
Software
EU registration type
Standard device
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 (K153736)

and 2 more cleared under K153736

Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES.

Other devices from Pie Medical Imaging B.V.

See all devices from Pie Medical Imaging B.V. →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)