# K012239: Modifications to Eub-525 Diagnostic Ultrasound Scanner; Eub-2000 Diagnostic Ultrasound Scanner; SP-711 Sonoprobe System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp.
- Decided: Aug 10, 2001 after 24 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: 2 generations back to K954220 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981434: Eup-OL334 Laparascopicprobe, Hitachi Medical Corp. of America (1998) Summary page 1.
- K011252: Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System, Hitachi Medical Corp. (2001) Summary page 1.

## Indications for use
The intended use of the subject device is for endoscopic observation of the gastrointestinal tract (esophagus, stomach, duodenum, large intestine) and biliary system (pancreato-biliary ducts).

Source page: https://510kreport.com/device/K012239
Methodology: https://510kreport.com/methodology