# K141870: Breast Volume Navigator

- Pathway: 510(k) (Traditional)
- Applicant: Metritrack, LLC
- Decided: Aug 7, 2014 after 27 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922470 (1992). 12 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963807: Tomtec Echo-Scan, Tomtec Imaging Systems, Inc. (1996) Summary page 4.
- K002807: 3D Organ Assessment W/ Magnetic Position Sensing, Acuson Corp. (2000) Summary page 4.
- K052355: Automated Breast Ultrasound System, Model Abus, U-Systems, Inc. (2005) Summary page 4.

## Most influential descendants
- K211098: Breast Volume Navigator (BVN) Model G-2000 (2021), 0 descendants of its own
- K190314: Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 (2019), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K141870
Methodology: https://510kreport.com/methodology