# K032503: Eub-5500 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Aug 22, 2003 after 9 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 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 no predicate by number.

## Most influential descendants
- K041395: EG-3630UR (2004), 4 descendants of its own
- K061068: EG-3670URK (2006), 3 descendants of its own
- K090196: EG-3670URK (2009), 2 descendants of its own
- K130206: Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision Preirus (2013), 1 descendant of its own
- K231813: Ultrasonic Gastrovideoscope (2024), 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/K032503
Methodology: https://510kreport.com/methodology