# K061608: Modification to Eub-5500 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Corp.
- Decided: Nov 22, 2006 after 166 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

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

Source page: https://510kreport.com/device/K061608
Methodology: https://510kreport.com/methodology