# K962308: EUB-905

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: Jul 17, 1996 after 30 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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
Probes available with the EUB-905 are intended for the following general clinical uses: Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small organ, Peripheral Vascular, Trans-rectal and Transvaginal.

Source page: https://510kreport.com/device/K962308
Methodology: https://510kreport.com/methodology