# K171709: BR-FHUS Viewer 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Taihao Medical, Inc.
- Decided: Oct 20, 2017 after 134 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: 8 generations back to K913770 (1991). 70 ancestors in all.
1 later device descends from it; 1 cites it directly.
6 of 72 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123901: Tractus Tissuemapper Reviewer 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 Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist physicians with manipulation and analysis tools in reviewing breast ultrasound images. Images and data are previously recorded from various imaging systems and other sources such as calibrated spatial positioning devices. BR-FHUS Viewer 1.0 provides the capability to visualize two-dimensional ultrasound images along with the scanning paths and position information of probe that stored in the DICOM file in advance.

Source page: https://510kreport.com/device/K171709
Methodology: https://510kreport.com/methodology