# K080930: Modification to Automated Breast Ultrasound System, Model Abus

- Pathway: 510(k) (Traditional)
- Applicant: U-System, Inc.
- Decided: Aug 7, 2008 after 127 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922470 (1992). 9 ancestors in all.
3 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)
- K052355: Automated Breast Ultrasound System, Model Abus, U-Systems, Inc. (2005) Summary page 1.
- K023720: Sonoline Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K092067: Abvs Workplace (2009), 2 descendants of its own
- K151075: BR-ABVS Viewer 1.0 (2016), 1 descendant of its own
- K180641: Invenia ABUS Viewer (2018), 0 descendants of its own

## Recalls of this device
- May 16, 2013 · Class II · Z-1587-2013: Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user manual contains the Indication for Use of the soma v Platinum ABUS [a 510(k) product].

## Indications for use
An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts and accessories. The device 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 or a handheld transducer. The device is not intended to be used as a replacement for screening mammography.

Source page: https://510kreport.com/device/K080930
Methodology: https://510kreport.com/methodology