510(k) · Cleared
ClearedBreast Volume Navigator (BVN) Model G-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metritrack, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 26, 2021 as substantially equivalent to K141870 (Metritrack, LLC, 2014) and 2 other predicates after a 43-day review. Its family tree reaches back 9 generations to 1994. 6 of the 104 devices in its family, counting itself, have a Class I recall.
- Decided
- May 26, 2021
- Review
- 43 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K911783 (1994). 103 ancestors in all, the oldest K844472 (1985). No later device cites it as a predicate yet. 6 of the 104 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 5 generations between
- 3 generations backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- 2 generations backK131489 Tractus Tissuemapper Image Recording System ApplicationTractus Corporation · 2013
- 1 generation backK171309 BR-FHUS Navigation 1.0Taihao Medical, Inc. · 2017
- This deviceK211098 Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 8 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 7 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 5 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 4 generations backK080624 Navstationirad Emt, Version 1.1Cas Innovations AG · 2008
- 3 generations backK092619 Etrax Needle System, Etrax Variable Angle Needle Guidance System…Civco · 2009 · Recalled
- 2 generations backK131489 Tractus Tissuemapper Image Recording System ApplicationTractus Corporation · 2013
- 1 generation backK171309 BR-FHUS Navigation 1.0Taihao Medical, Inc. · 2017
- This deviceK211098 Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −8 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −7 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −5 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −4 | K080624 | Navstationirad Emt, Version 1.1 | Cas Innovations AG | 2008 | — |
| −3 | K092619 | Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax… | Civco | 2009 | 17 |
| −2 | K131489 | Tractus Tissuemapper Image Recording System Application | Tractus Corporation | 2013 | — |
| −1 | K171309 | BR-FHUS Navigation 1.0 | Taihao Medical, Inc. | 2017 | — |
| 0 (this device) | 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 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 1 |
| 1997 | 3 | 0 |
| 1998 | 8 | 1 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 10 | 0 |
| 2003 | 11 | 0 |
| 2004 | 3 | 1 |
| 2005 | 7 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (3)
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 |
|---|---|---|---|
| * | K141870 | Breast Volume NavigatorSummary page 4…evice Class: II Primary Product Code IYO, ITX, LLZ Predicate Devices: Primary predicate: MetriTrack, LLC Breast Volume Navigator (BVN™) (K141870) Reference device: TaiHao Medical Inc. BR-FHUS Navigation 1.0 (K171309) Reference device: TaiHao Medical Inc. BR-FHUS Viewer (K17… | 2014 |
| * | K171309 | BR-FHUS Navigation 1.0Summary page 4…O, ITX, LLZ Predicate Devices: Primary predicate: MetriTrack, LLC Breast Volume Navigator (BVN™) (K141870) Reference device: TaiHao Medical Inc. BR-FHUS Navigation 1.0 (K171309) Reference device: TaiHao Medical Inc. BR-FHUS Viewer (K171709) Indications for Use / Intended Use: The Breast Volume Navigator… | 2017 |
| * | K171709 | BR-FHUS Viewer 1.0Summary page 4…LLC Breast Volume Navigator (BVN™) (K141870) Reference device: TaiHao Medical Inc. BR-FHUS Navigation 1.0 (K171309) Reference device: TaiHao Medical Inc. BR-FHUS Viewer (K171709) Indications for Use / Intended Use: The Breast Volume Navigator (BVN™) is an add-on accessory for existing ultrasound imaging s… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 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 27 years and passes through 8 companies; a new generation was cleared every 3.6 years on median.
- 28 of the 103 ancestors have a recall of any class; 6 have a Class I recall.
- 1 other device also cites its predicate K141870.
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. 2021, 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?
The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2-dimensional image slices throughout a volume of interest. The BVN is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing. The BVN is intended to assist health care providers…
Read the full statement (318 words)
The Breast Volume Navigator (BVN) is an add-on accessory for existing ultrasound imaging systems and is intended to control position and movement of ultrasound transducers for the systematic acquisition of 2-dimensional image slices throughout a volume of interest. The BVN is intended to acquire, analyze, store and retrieve digital ultrasound images for computerized 3-dimensional image processing.
The BVN is intended to assist health care providers trained in breast ultrasound with tools for electromagnetic tracking of instruments with respect of breast ultrasound images generated from FDA cleared hand-held ultrasound devices.
The BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with a linear array transducer.
The BVN is indicated for use as an adjunct to hand-held breast ultrasound to assist the health care providers trained in breast ultrasound 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.
The BVN Software Application is intended as a standalone software device installed on a 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. The BVN Software Application provides the capability to visualize ultrasound images along with the scanning paths and position information of the probe that is stored in the DICOM file in advance.
The BVN will allow exporting to any third-party application that has the appropriate level of DICOM compliance. The BVN is intended as a general-purpose digital 3D breast ultrasound image processing tool for radiology and surgery.
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.
The device is not intended to be used as a replacement for screening mammography.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211098: Breast Volume Navigator (BVN) Model G-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211098
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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