# K053258: Eub-6500 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Corp.
- Decided: Dec 9, 2005 after 17 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
Longest line of descent: 1 generation back to K013723 (2002). 1 ancestor in all.
4 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner, Hitachi Medical Corp. (2002) Summary page 5.

## Most influential descendants
- K110241: Endologix Guidewire (2011), 2 descendants of its own
- K152177: SonoStik IV Guide Wire Introducer (2015), 1 descendant of its own
- K243061: SonoStik Guide Wire Introducer (2024), 0 descendants of its own
- K082656: Model FF Sonic US-750 XT Diagnostic Ultrasound System 3D Imaging Unit (2008), 0 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/K053258
Methodology: https://510kreport.com/methodology