# K151075: BR-ABVS Viewer 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Taihao Medical, Inc.
- Decided: Jan 15, 2016 after 268 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922470 (1992). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092067: Abvs Workplace, Siemens AG Medical Solutions (2009) Summary page 5.

## Most influential descendants
- K180641: Invenia ABUS Viewer (2018), 0 descendants of its own

## Indications for use
BR-ABVS Viewer 1.0 is intended as a standalone software device installed on a standalone windows-based computer to assist the physician to visualize any orientation of three-dimensional (3-D) breast ultrasound images generated by Siemens ACUSON S2000 Automated Breast Volume Scanner, ABVS (cleared in K081148). The software device is indicated for use to assist the physicians in their review and analysis of the 3-D breast ultrasound images generated by ABVS. Caution: Federal law restricts this device to sale by or on the order of a physician.

Source page: https://510kreport.com/device/K151075
Methodology: https://510kreport.com/methodology