# K991671: Hdi 5000 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Technology Laboratories, Inc.
- Decided: Jun 18, 1999 after 32 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.
809 later devices descend from it; 2 cite it directly.
2 of 810 devices 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) General Electric System Five: named in the summary without a submission number

## 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
- K080935: Sonix MDP Ultrasound Scanner (2008), 584 descendants of its own
- K083095: Sonixtouch Ultrasound System (2008), 582 descendants of its own
- K092271: GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 (2009), 569 descendants of its own

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K991671
Methodology: https://510kreport.com/methodology