# K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option

- Pathway: 510(k) (Traditional)
- Applicant: Koelis
- Decided: Jul 26, 2013 after 67 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). 11 ancestors in all.
6 later devices descend from it; 3 cite 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)
- K100793: Urostation 3D Prostate Suite, Koelis (2010) Summary page 4.

## Most influential descendants
- 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
- K170521: Trinity/3D Prostate Suite (2017), 0 descendants of its own

## Indications for use
UROSTATION - 3D PROSTATE SUITE with MRI/3DTRUS fusion option and with Second Look 3DTRUS fusion option is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of the prostate gland and for the 3D transrectal ultrasound based fusion of multiple imaging modalities (ultrasound, MRI) in order to map such prostate gland. Additional software features include patient data management, multimodal data communication, multi-planar reconstruction, surface and volume rendering, organ delineation, region of interest delineation, 3D image registration and data reporting.

Source page: https://510kreport.com/device/K131448
Methodology: https://510kreport.com/methodology