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3mensio Workstation 8.1

by Pie Medical Imaging B.V.

3mensio Workstation 8.1 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Pie Medical Imaging B.V., cleared under FDA 510(k) K153736 on 27 May 2016 and listed in FDA GUDID since 25 Nov 2016 (UDI-DI 08056304453488), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K153736

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08056304453488 UDI-DI Date25 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK153736 Date27 May 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153736 decided 27 May 2016 Active
  • FDA GUDID UDI-DI 08056304453488 listed 25 Nov 2016 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

3 dated events

  1. Cleared FDA 510(k) K153736
  2. Listed FDA GUDID 08056304453488
  3. Recall initiated FDA recalls Z-2297-2025

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
3mensio Workstation
Generic name
Radiology DICOM image processing application software
Model / reference
8.1
Primary DI / UDI-DI
08056304453488
510(k) Number
FDA product code
LLZ
GMDN term
Radiology DICOM image processing application software
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

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 Radiology DICOM image processing application software.

Other devices from Pie Medical Imaging B.V.

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

Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)