# K052355: Automated Breast Ultrasound System, Model Abus

- Pathway: 510(k) (Special)
- Applicant: U-Systems, Inc.
- Decided: Sep 14, 2005 after 16 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: 3 generations back to K922470 (1992). 8 ancestors in all.
64 later devices descend from it; 5 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System, U-Systems, Inc. (2003) Summary page 1.
- K023720: Sonoline Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 1.

## Most influential descendants
- K080555: Sofia Automated Tomographic Ultrasound (Atus) (2008), 53 descendants of its own
- K123209: Softvue (2013), 50 descendants of its own
- K142517: SoftVue (2014), 49 descendants of its own
- K150949: FibroScan (2015), 42 descendants of its own
- K160524: FibroScan 530 Compact (2016), 41 descendants of its own

## Indications for use
An ultrasonic pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth or 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.

Source page: https://510kreport.com/device/K052355
Methodology: https://510kreport.com/methodology