# K092067: Abvs Workplace

- Pathway: 510(k) (Traditional)
- Applicant: Siemens AG Medical Solutions
- Decided: Sep 18, 2009 after 71 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: 5 generations back to K922470 (1992). 10 ancestors in all.
2 later devices descend 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)
- K080930: Modification to Automated Breast Ultrasound System, Model Abus, U-System, Inc. (2008) Summary page 2.

## Most influential descendants
- K151075: BR-ABVS Viewer 1.0 (2016), 1 descendant of its own
- K180641: Invenia ABUS Viewer (2018), 0 descendants of its own

## Indications for use
The ABVS Workplace is intended to display ultrasound images of the breast acquired from B-mode imaging using an automatic or handheld scanning linear transducer. The images may be reviewed and analyzed by the physician. The ABVS Workplace is indicated for use as an adjunct to mammography. The ABVS Workplace is not intended to be used as a replacement for screening mammography.

Source page: https://510kreport.com/device/K092067
Methodology: https://510kreport.com/methodology