510(k) · Cleared

Cleared

BR-FHUS Viewer 1.0

K171709510(k) TraditionalCleared Oct 20, 2017134-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Taihao Medical, Inc. · LLZ System, Image Processing, Radiological

Cleared on Oct 20, 2017 as substantially equivalent to K123901 (Tractus Corporation, 2013) after a 134-day review. Its family tree reaches back 8 generations to 1991. 6 of the 72 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Oct 20, 2017
Review: 134 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 8 generations to K913770 (1991). 70 ancestors in all, the oldest K882383 (1988). 1 later device descends from it, 1 citing it directly. 6 of the 72 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 8 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
7 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
6 generations backK020483 Advantage Workstation 4.1GE Medical Systems · 2002 · Recalled
5 generations backK033400 Seno AdvantageGe Medical Systems W-400 · 2003 · Recalled
4 generations backK043216 Cadstream Version 4.0Confirma, Inc. · 2005
3 generations backK070244 AEGISSentinelle Medical, Inc. · 2007
2 generations backK093672 Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc. · 2009
1 generation backK123901 Tractus Tissuemapper Reviewer ApplicationTractus Corporation · 2013
This deviceK171709 BR-FHUS Viewer 1.0Taihao Medical, Inc. · 2017
Descendant · cites it directly · 0 of its ownK211098 Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021

Class I recalls in this family

K040050 Instatrak System with Multiple Dataset…4 generations back · 2004
K994270 Instatrak 3000 System with Fluorotrak Module…4 generations back · 2000
K983529 Instatrak 30004 generations back · 1998
K982994 Skull Base Instatrak System4 generations back · 1998

Most influential descendants

Showing 1 of 1 · See all

K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−8	K913770	Advantage V.S. CT/MR Rad Diagnostic Workstation	General Electric Co.	1991	—
−7	K960613	GE Advantage Windows Review Workstation	GE Medical Systems	1996	—
−6	K020483	Advantage Workstation 4.1	GE Medical Systems	2002	2
−5	K033400	Seno Advantage	Ge Medical Systems W-400	2003	6
−4	K043216	Cadstream Version 4.0	Confirma, Inc.	2005	—
−3	K070244	AEGIS	Sentinelle Medical, Inc.	2007	—
−2	K093672	Aegis Navigation Anda Egis Pelvic Application	Sentinelle Medical, Inc.	2009	—
−1	K123901	Tractus Tissuemapper Reviewer Application	Tractus Corporation	2013	—
0 (this device)	K171709	BR-FHUS Viewer 1.0	Taihao Medical, Inc.	2017	—
+1	K211098	Breast Volume Navigator (BVN) Model G-2000	Metritrack, Inc.	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1993	1	0
1994	2	0
1995	2	0
1996	5	1
1997	2	0
1998	10	3
1999	5	0
2000	7	1
2001	7	0
2002	7	0
2003	5	0
2004	2	1
2005	3	0
2006	2	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K171709, 1991–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

6 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K123901	Tractus Tissuemapper Reviewer Application Summary page 4 …Number: 21 CFR 892.2050 Classification Product Code: LLZ Classification: Class II Predicate Device: Tractus TissueMapper Reviewer Application (K123901) 5-1…	Tractus Corporation	2013	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K211098	Breast Volume Navigator (BVN) Model G-2000	Metritrack, Inc.	2021	0

Has anything in its family been recalled? (6 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 4 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 12 Class I recalls
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 4 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K960330InstatrakVisualization Technology, Inc. · 1996 · 4 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall

Nearest 5 of 6; all are on the web page.

What does this lineage say?

The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
23 of the 70 ancestors have a recall of any class; 6 have a Class I recall.
Of its descendants, K211098 (Metritrack, Inc., 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K171709 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171709: BR-FHUS Viewer 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171709

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026