# K160376: EndoSize

- Pathway: 510(k) (Special)
- Applicant: Therenva Sas
- Decided: Apr 12, 2016 after 62 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: 7 generations back to K954678 (1996). 8 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141475: Endosize, Therenva Sas (2014) Summary page 4.

## Most influential descendants
- 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
- K222664: Sim&Size (2023), 2 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/K160376
Methodology: https://510kreport.com/methodology