# 3mensio Workstation 10.4

> Active: European Union and United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/3mensio-workstation-10-4>
- Manufacturer: [Pie Medical Imaging B.V.](https://devicerts.com/manufacturers/pie-medical-imaging-b-v) (FDA registration: Netherlands)
- Device class: Class IIb (EU MDR); Class II (US FDA)
- FDA product code: LLZ
- EMDN: Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES
- GMDN: Radiology DICOM image processing application software (57812)

## Registrations and authorizations

- **EUDAMED** · CE/MDR · European Union · Basic UDI-DI 8056304453mensioWSZ9 · UDI-DI 08056304454942 · registered 2026-06-15 · status: Withdrawn
- **GUDID** · GUDID listing · United States · UDI-DI 08056304454942 · listed 2023-04-17 · status: Listed (GUDID: in commercial distribution)
- **GUDID** · FDA 510(k) · United States · K153736 · issued 2016-05-27 · status: Active · from GUDID

## Recalls

- Z-2297-2025 · Class II · ongoing · initiated 2025-07-14: 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

## Identity

- Trade name: 3mensio Workstation [EUDAMED, FDA GUDID (AccessGUDID)]
- Generic name: Radiology DICOM image processing application software [FDA GUDID (AccessGUDID)]
- Model / reference: 10.4 [EUDAMED, FDA GUDID (AccessGUDID)]

## Identifiers

- Primary DI / UDI-DI: 08056304454942 [EUDAMED, FDA GUDID (AccessGUDID)]
- Basic UDI-DI: 8056304453mensioWSZ9 [EUDAMED]
- Direct marketing DI: 08056304454942 [EUDAMED]
- 510(k) Number: K153736 [FDA GUDID (AccessGUDID)]
- FDA product code: LLZ [FDA GUDID (AccessGUDID)]
- EMDN code: Z11039082 [EUDAMED]
- GMDN term: Radiology DICOM image processing application software (57812) [FDA GUDID (AccessGUDID)]

## Classification

- Device class: Class IIb [EUDAMED]; Class II [FDA GUDID (AccessGUDID)]
- Regulation number: 892.2050 [FDA GUDID (AccessGUDID)]
- Special device type: Software [EUDAMED]
- EU registration type: Standard device [EUDAMED]
- GUDID distribution status: In Commercial Distribution [FDA GUDID (AccessGUDID)]

## Properties

- Measuring function: Yes [EUDAMED]
- Prescription use: Yes [FDA GUDID (AccessGUDID)]
- Manufacturing date: Yes [FDA GUDID (AccessGUDID)]
- Supplied sterile: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Sterilise before use: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Single use: No [FDA GUDID (AccessGUDID)]
- Implantable: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reusable: No [EUDAMED]
- Contains latex: No [EUDAMED, FDA GUDID (AccessGUDID)]
- Reprocessed single-use device: No [EUDAMED]
- Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No [EUDAMED]
- Incorporates a substance derived from human blood or plasma: No [EUDAMED]
- Contains human tissues or cells: No [EUDAMED]
- Contains animal tissues or cells: No [EUDAMED]
- Contains endocrine-disrupting substances: No [EUDAMED]
- Administering medicine: No [EUDAMED]
- Incorporates a medicinal substance: No [EUDAMED]
- Over-the-counter: No [FDA GUDID (AccessGUDID)]
- Convenience kit: No [FDA GUDID (AccessGUDID)]
- Combination product: No [FDA GUDID (AccessGUDID)]
- HCT/P: No [FDA GUDID (AccessGUDID)]
- Premarket exempt: No [FDA GUDID (AccessGUDID)]
- Lot / batch number: No [FDA GUDID (AccessGUDID)]
- Serial number: No [FDA GUDID (AccessGUDID)]
- Expiration date: No [FDA GUDID (AccessGUDID)]

## Source and citation

- Cite as: 3mensio Workstation 10.4, Pie Medical Imaging B.V. deviCERTS medical device catalogue. https://devicerts.com/devices/3mensio-workstation-10-4 (data as of 2026-11-15).
- Data sources: [FDA GUDID (AccessGUDID)](https://accessgudid.nlm.nih.gov/), [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA recalls](https://open.fda.gov/apis/device/recall/)
- Registry records last synced: 2026-10-23
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/3mensio-workstation-10-4.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/3mensio-workstation-10-4
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.