# K250330: 3mensio Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Nov 3, 2025 after 271 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 20 generations back to K935595 (1995). 156 ancestors in all.
No later device cites it as a predicate yet.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153736: 3mensio Workstation, Pie Medical Imaging BV (2016) Summary page 5.
- K213544: Tomtec-Arena, Tomtec Imaging Systems GmbH (2022) Summary page 5.

## Recalls of this device
- May 7, 2026 · Class II · Z-2767-2026: User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical dimension, if all the

## Indications for use
Standalone software for medical image analysis intended for advanced visualization and quantitative analysis for diagnostics in the field of cardiology or radiology by means of enabling 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) 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 CMRP, Slabbing, MIP, AIP, MinlP - Measurement and annotation tools - Reporting tools

Source page: https://510kreport.com/device/K250330
Methodology: https://510kreport.com/methodology