# K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging

- Pathway: 510(k) (Traditional)
- Applicant: Atl Ultrasound, Inc.
- Decided: Jul 13, 2000 after 13 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.
823 later devices descend from it; 8 cite it directly.
2 of 824 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
- K034003: Hdi 5000 Diagnostic Ultrasound System (2004), 677 descendants of its own
- K053069: Sonosite Micromaxx Diagnostic Ultrasound System (C3 Series) (2005), 676 descendants of its own
- K020630: Ultrasonix Ergosonix 500 Ultrasound Scanner (2002), 595 descendants of its own
- K042326: Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner (2004), 590 descendants of its own
- K061827: Sonix Ultrasound Scanner (2006), 586 descendants of its own

Source page: https://510kreport.com/device/K002003
Methodology: https://510kreport.com/methodology