# K171309: BR-FHUS Navigation 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Taihao Medical, Inc.
- Decided: Sep 29, 2017 after 149 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911783 (1994). 67 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131489: Tractus Tissuemapper Image Recording System Application, Tractus Corporation (2013) Summary page 4.

## Most influential descendants
- K211098: Breast Volume Navigator (BVN) Model G-2000 (2021), 0 descendants of its own

## Indications for use
BR-FHUS Navigation 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with tools for electromagnetic tracking of instruments in respect of breast ultrasound images generated from FDA cleared handheld ultrasound devices. The device is not intended to be used in the environment of strong magnetic or electromagnetic fields, such as in Magnetic Resonance Imaging (MRI) room. BR-FHUS Navigation 1.0 is indicated for use as an adjunct to handheld breast ultrasound to assist the physicians in their scanning process. The scanning paths are displayed on a route map and provide quality control of scanning to provide an overall observation of scanning process.

Source page: https://510kreport.com/device/K171309
Methodology: https://510kreport.com/methodology