# K961229: HR12000 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: International Ultrasound Corp.
- Decided: May 29, 1997 after 426 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K981834: Perception Inc, GPS-6TBMD Diagnostic Ultrasound System (1998), 0 descendants of its own

## Indications for use
The HRI2000 system connected with a probe enables real time two dimensional diagnostic ultrasound imaging. The system offers options for each probe, each optimized to image structure and orientation of tissues during specific clinical applications. These include general abdominal, small organ, gynecological and urological, vascular and cardiac anatomy.

Source page: https://510kreport.com/device/K961229
Methodology: https://510kreport.com/methodology