# K011224: Hdi 5000 Ultrasound System with Assisted Border Detection (Abd), Xres Imaging, and Panoramic Measurement Capability

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laboratories, Inc.
- Decided: May 4, 2001 after 14 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.
691 later devices descend from it; 10 cite it directly.
0 of 692 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030949: Titan High Resolution Ultrasound System (2003), 683 descendants of its own
- K043559: Sonosite High-Resolution Diagnostic Ultrasound System (C3 Series) (2005), 678 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K080223: Zura Tee System (2008), 583 descendants of its own

Source page: https://510kreport.com/device/K011224
Methodology: https://510kreport.com/methodology