510(k) · Cleared
ClearedBR-FHUS Navigation 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taihao Medical, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Sep 29, 2017 as substantially equivalent to K131489 (Tractus Corporation, 2013) after a 149-day review. Its family tree reaches back 8 generations to 1994. 6 of the 69 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Sep 29, 2017
- Review
- 149 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K911783 (1994). 67 ancestors in all, the oldest K844472 (1985). 1 later device descends from it, 1 citing it directly. 6 of the 69 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 4 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 3 generations backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- 2 generations backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- 1 generation backK131489 Tractus Tissuemapper Image Recording System ApplicationTractus Corporation · 2013
- This deviceK171309 BR-FHUS Navigation 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
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 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −4 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −3 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| −2 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| −1 | K131489 | Tractus Tissuemapper Image Recording System Application | Tractus Corporation | 2013 | — |
| 0 (this device) | K171309 | BR-FHUS Navigation 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 |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 3 | 0 |
| 1998 | 7 | 1 |
| 1999 | 5 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 7 | 0 |
| 2003 | 6 | 0 |
| 2004 | 2 | 1 |
| 2005 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K131489 | Tractus Tissuemapper Image Recording System ApplicationSummary page 4…umber: 21 CFR 892.1560 Classification Product Code: IYO Classification: Class II Predicate Device: Tractus TissueMapper Image Recording System (K131489) 5-1… | 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 | Decided | Descendants |
|---|---|---|---|
| K211098 | Breast Volume Navigator (BVN) Model G-2000 | 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 · 3 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 · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 4 generations back · ◆ on the line of descent in 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 · ◆ on the line of descent in 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 23 years and passes through 7 companies; a new generation was cleared every 3.6 years on median.
- 22 of the 67 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 IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
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…
Read the full statement (109 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171309: BR-FHUS Navigation 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/K171309
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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