# K120367: 3MENSIO Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Pie Medical Imaging BV
- Decided: Apr 17, 2012 after 71 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954678 (1996). 6 ancestors in all.
49 later devices descend from it; 4 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072653: 3VISEON/Surgery, 3Mensio Medical Imaging BV (2008) Summary page 1.

## Most influential descendants
- K153736: 3mensio Workstation (2016), 19 descendants of its own
- K141475: Endosize (2014), 16 descendants of its own
- K160376: EndoSize (2016), 13 descendants of its own
- K171534: SurgicalPreview (2017), 10 descendants of its own
- K190049: Sim&Size (2019), 8 descendants of its own

## 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 To facilitate the above, 3mensio Workstation provides general functionality such as: *Segmentation of cardiovascular structures *Automatic and manual centerline detection *Visualization and image reconstruction techniques: 20 review, Volume Rendering, MPR, Curved MPR, Stretched CMRP, Slabbing, MIP, AlP, MinIP * Measurement and annotation toots *Reporting tools

Source page: https://510kreport.com/device/K120367
Methodology: https://510kreport.com/methodology