# K160934: UC-CARE NaviGo Workstation

- Pathway: 510(k) (Traditional)
- Applicant: UC-CARE, Ltd.
- Decided: Feb 6, 2017 after 308 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). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100784: UC-Care Navigo Sytem, UC-CARE, Ltd. (2011) Summary page 4.
- K131448: 3D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS Fusion Option, Koelis (2013) Summary page 4.

## Most influential descendants
- K173054: Navigo Workstation Version 2.0 (2018), 1 descendant of its own
- K250664: Navigo Workstation 2.3 (FPRMC00039) (2025), 0 descendants of its own

## Indications for use
The UC-CARE NaviGo Workstation is an adjunctive tool for ultrasound guided procedures and is intended to be used by physicians in the clinic or hospital for 2-D and 3-D visualization of ultrasound images of the prostate gland. The NaviGo™ Workstation offers the ability to fuse DICOM originated information (e.g. MRI) with the ultrasound images and thus superimpose information from one modality onto the other. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3-D image registration. The device is specifically indicated to provide information on regional orientation within the prostate to assist needle targeted procedures (e.g. biopsy) regions of interest display, procedures planning and, reconstruction of a 3D rendered surface model of the prostate display needle locations that have been selected by the physician, as well as storage and future retrieval of this information.

Source page: https://510kreport.com/device/K160934
Methodology: https://510kreport.com/methodology