# K022517: Usi-2000 Ultrasound System with Automated Scanning Accessory

- Pathway: 510(k) (Traditional)
- Applicant: U-Systems, Inc.
- Decided: Dec 24, 2002 after 147 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
66 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) LABSONICS Ultrasound Breast Scanner: named in the summary without a submission number
- (no number) Sonopsy LA System: named in the summary without a submission number

## Most influential descendants
- K032640: Full Field Breast Imaging (Ffbu) Diagnostic Ultrasound System (2003), 65 descendants of its own
- 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

## Indications for use
The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. 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. Imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers reflected ultrasound signals displayed on a computer screen. Automatic scanning obtains multiple, sequential two-dimensional images, which can be compiled into a three-dimensional data set for viewing in three planes.

Source page: https://510kreport.com/device/K022517
Methodology: https://510kreport.com/methodology