# K100793: Urostation 3D Prostate Suite

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: Sep 22, 2010 after 184 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). 10 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081093: 3-D Imaging Workstation, Eigen, LLC (2008) Summary page 1.

## Most influential descendants
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option (2013), 6 descendants of its own
- K160934: UC-CARE NaviGo Workstation (2017), 2 descendants of its own
- K173054: Navigo Workstation Version 2.0 (2018), 1 descendant of its own
- K160357: Trinity (2016), 1 descendant of its own
- K250664: Navigo Workstation 2.3 (FPRMC00039) (2025), 0 descendants of its own

## Indications for use
UROSTATION - 3D PROSTATE SuITE is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound imnages of the prostate gland. Additional software features include patient data management, multi-planar reconstruction and 3D image registration.

Source page: https://510kreport.com/device/K100793
Methodology: https://510kreport.com/methodology