# K954220: EUB-8000

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: May 7, 1997 after 604 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.
13 later devices descend from it; 1 cites it directly.
0 of 14 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
- K981434: Eup-OL334 Laparascopicprobe (1998), 12 descendants of its own
- K013640: EG-3630UR, Ultrasund Video Gastroscope (2002), 9 descendants of its own
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700 (2007), 8 descendants of its own
- K111243: Fujinon Ultrasonic Processor (2011), 7 descendants of its own
- K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2 (2012), 4 descendants of its own

## Indications for use
Probes available with the EUB-8000 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral Vascular, Biopsy, Transrectal, Transvaginal, and Neonatal Cephalic.

Source page: https://510kreport.com/device/K954220
Methodology: https://510kreport.com/methodology