# K153736: 3mensio Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: May 27, 2016 after 151 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K954678 (1996). 18 ancestors in all.
19 later devices descend from it; 11 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120367: 3MENSIO Workstation, Pie Medical Imaging BV (2012) Summary page 4.
- K153022: Philips IntelliSpace Cardiovascular, Philips Medical Systems Nethrlands BV (2015) Summary page 4.

## Most influential descendants
- K202212: TruPlan (2021), 3 descendants of its own
- K222593: TruPlan Computed Tomography (CT) Imaging Software (2023), 2 descendants of its own
- K191585: iNtuition-Structural Heart Module (2019), 2 descendants of its own
- K190874: Materialise Mimics Enlight (2019), 2 descendants of its own
- K250337: AiORTA - Plan (2025), 1 descendant of its own

## Recalls of this device
- Jul 14, 2025 · Class II · Z-2297-2025: 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 chang

## Indications for use
3mensio Workstation enables visualization and measurement of structures of the heart and vessels for: * Pre-operational planning and sizing for cardiovascular interventions and surgery * Postoperative evaluation * Support of clinical diagnosis by quantifying dimensions in coronary arteries * Support of clinical diagnosis by quantifying calcifications (calcium scoring) in the coronary arteries To facilitate the above, the 3mensio Workstation provides general functionality such as: » Segmentation of cardiovascular structures » Automatic and manual centerline detection * Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR, Curved MPR, Stretched CMPR, Slabbing, MIP, AIP, MinIP * Measurement and annotation tools * Reporting tools

Source page: https://510kreport.com/device/K153736
Methodology: https://510kreport.com/methodology