# K013848: U-Systems Diagnostic Ultrasound System U-2000

- Pathway: 510(k) (Traditional)
- Applicant: U-Systems, Inc.
- Decided: Apr 8, 2002 after 139 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) Echotech 3D Freescan: named in the summary without a submission number

## Indications for use
The modified U-2000 is indicated for acquisition of related sets of 2D ultrasound images and 3 dimensional reconstruction of diagnostic ultrasound images. It is intended to acquire, analyze, store, and retrieve digital ultrasound images for computerized 3 dimensional image processing.

Source page: https://510kreport.com/device/K013848
Methodology: https://510kreport.com/methodology