# K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: U-Systems, Inc.
- Decided: Sep 11, 2003 after 15 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: 1 generation back to K022517 (2002). 1 ancestor in all.
65 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022517: Usi-2000 Ultrasound System with Automated Scanning Accessory, U-Systems, Inc. (2002)

## Most influential descendants
- K052355: Automated Breast Ultrasound System, Model Abus (2005), 64 descendants of its own
- 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

## Indications for use
U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations. U-Systems L 9-5 XW MHz Transducer is intended for diagnostic breast examinations.

Source page: https://510kreport.com/device/K032640
Methodology: https://510kreport.com/methodology