# K034003: Hdi 5000 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Philips Ultrasound, Inc.
- Decided: Jan 8, 2004 after 15 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001400 (2000). 7 ancestors in all.
677 later devices descend from it; 4 cite it directly.
0 of 685 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.
- K991671: Hdi 5000 Diagnostic Ultrasound System, Advanced Technology Laboratories, Inc. (1999) Summary page 1.
- K002003: Hdi 5000 Ultrasound System with Extended Field of View Imaging, Atl Ultrasound, Inc. (2000) Summary page 1.
- K003525: Voluson 730 Diagnostic Ultrasound System, Medison America, Inc. (2000) Summary page 1.
- K940942: Combison 530 Diagnostic Ultrasound Scanner, Medison America, Inc. (1997) Summary page 1.
- K023720: Sonoline Antares Ultrasound System, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- 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
- K110943: Logiq E9 (2011), 472 descendants of its own

## Recalls of this device
- Sep 5, 2025 · Class III · Z-1618-2026: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2346-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2358-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
- Jul 3, 2025 · Class III · Z-2357-2025: To provide clarification and labelling to define the useful life of ultrasound transducers in the field.

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

Source page: https://510kreport.com/device/K034003
Methodology: https://510kreport.com/methodology