510(k) · Cleared
ClearedBreast Volume Navigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metritrack, LLC · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Aug 7, 2014 as substantially equivalent to K963807 (Tomtec Imaging Systems, Inc., 1996) and 2 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 7, 2014
- Review
- 27 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K922470 (1992). 12 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 3 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 2 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 1 generation backK052355 Automated Breast Ultrasound System, Model AbusU-Systems, Inc. · 2005
- This deviceK141870 Breast Volume NavigatorMetritrack, LLC · 2014
- Descendant · cites it directly · 0 of its ownK211098 Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK190314 Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000Mednovel Technology, Ltd. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −3 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −2 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −1 | K052355 | Automated Breast Ultrasound System, Model Abus | U-Systems, Inc. | 2005 | — |
| 0 (this device) | K141870 | Breast Volume Navigator | Metritrack, LLC | 2014 | — |
| +1 | K211098 | Breast Volume Navigator (BVN) Model G-2000 | Metritrack, Inc. | 2021 | — |
| +1 | K190314 | Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 | Mednovel Technology, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 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.
Planning a device in IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K963807 | Tomtec Echo-ScanSummary page 4…sed Echo, Ultrasonic Regulation Number: 21 CFR 892.1560 Product Code: IYO Device Class: Class II Predicate Devices: TomTec Digital Ultrasound Image Analysis System (K963807) Acuson 3D Organ Assessment with Magnetic Position Sensing (K002807) U-Systems ABUS Diagnostic Ultrasound System (K052355)… | 1996 |
| * | K002807 | 3D Organ Assessment W/ Magnetic Position SensingSummary page 4…de: IYO Device Class: Class II Predicate Devices: TomTec Digital Ultrasound Image Analysis System (K963807) Acuson 3D Organ Assessment with Magnetic Position Sensing (K002807) U-Systems ABUS Diagnostic Ultrasound System (K052355) 1… | 2000 |
| * | K052355 | Automated Breast Ultrasound System, Model AbusSummary page 4…omTec Digital Ultrasound Image Analysis System (K963807) Acuson 3D Organ Assessment with Magnetic Position Sensing (K002807) U-Systems ABUS Diagnostic Ultrasound System (K052355) 1… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.1 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K211098 (Metritrack, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K963807.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (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 will allow exporting to any third party…
Read the full statement (136 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 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 BVN is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer.
The device is not intended to be used as a replacement for screening mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141870 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141870: Breast Volume Navigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141870
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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