# K141475: Endosize

- Pathway: 510(k) (Traditional)
- Applicant: Therenva Sas
- Decided: Jul 31, 2014 after 57 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: 6 generations back to K954678 (1996). 7 ancestors in all.
16 later devices descend from it; 2 cite it directly.
0 of 24 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 1.

## Most influential descendants
- 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
- K202322: Sim&Size (2020), 5 descendants of its own
- K212373: Sim&Size (2022), 3 descendants of its own

## Indications for use
EndoSize enables visualization and measurement of structures of the heart and vessels for pre-operational planning and sizing for cardiovascular interventions and surgery, and for postoperative evaluation. General functionalities are provided such as: * Segmentation of cardiovascular structures * Automatic and manual centerline detection * Visualization of CT scan images in every planes, 2D review, 3D reconstruction. Volume Rendering, MPR. Stretched CMPR * Measurement and annotation tools * Reporting tools

Source page: https://510kreport.com/device/K141475
Methodology: https://510kreport.com/methodology