# K100784: UC-Care Navigo Sytem

- Pathway: 510(k) (Traditional)
- Applicant: UC-CARE, Ltd.
- Decided: Nov 1, 2011 after 592 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.
3 later devices descend from it; 1 cites it directly.
0 of 14 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 2.

## 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
- K250664: Navigo Workstation 2.3 (FPRMC00039) (2025), 0 descendants of its own

## Indications for use
The UC-CARE NaviGom Workstation 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. Additional software features to assist biopsy procedures 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 biopsy procedures under standard ultrasound guidance, reconstruction of a 3D rendered surface model of the prostate and to display locations for biopsies that have been selected by the physician, as well as storage and future retrieval of this information.

Source page: https://510kreport.com/device/K100784
Methodology: https://510kreport.com/methodology