# K013902: U-Systems Diagnostic Ultrasound System Usi-2000

- Pathway: 510(k) (Traditional)
- Applicant: U-Systems, Inc.
- Decided: Jun 5, 2002 after 191 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.
No later device cites it as a predicate yet.
0 of 1 device 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) UltraGuide 1000 System: named in the summary without a submission number

## Indications for use
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs. The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures. The US1 Needle Guide accessory is intended for small parts use for breast biopsy. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: The US1 Needle Guide accessory is intended for small parts use for breast biopsy.

Source page: https://510kreport.com/device/K013902
Methodology: https://510kreport.com/methodology