# K082543: Sonocine Adjunctive Breast Ultrasound System (Abu), Model 100

- Pathway: 510(k) (Traditional)
- Applicant: Sonocine, Inc.
- Decided: Oct 14, 2008 after 41 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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)
- K070477: Orison Embrace System, Orison Corporation (2007) Summary page 2.
- K052355: Automated Breast Ultrasound System, Model Abus, U-Systems, Inc. (2005) Summary page 2.

## Most influential descendants
- K161354: MELODY, Remote Control System for Ultrasound Probe (2017), 1 descendant of its own
- K260190: Arthur (2026), 0 descendants of its own

## Indications for use
The SonoCine Adjunctive Breast Ultrasound System (ABU) Model 100 is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of the patient's breast when used with an automatic scanning linear array transducer. This device is not intended to be used as a replacement for screening mammography. Small Organ - Breast, B-Mode The SonoCine Adjunctive Breast Ultrasound System is intended for B-Mode ultrasonic imaging of a patient's breast.

Source page: https://510kreport.com/device/K082543
Methodology: https://510kreport.com/methodology