# K981434: Eup-OL334 Laparascopicprobe

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corp. of America
- Decided: Jul 27, 1998 after 97 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954220 (1997). 1 ancestor in all.
12 later devices descend from it; 3 cite 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)
- K954220: EUB-8000, Hitachi Medical Corp. of America (1997) Summary page 7.

## Cited in the summary but kept off the family tree
- K926208: Unnamed device. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Most influential descendants
- 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
- K181763: FUJIFILM Ultrasonic Endoscope (2018), 3 descendants of its own

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

Source page: https://510kreport.com/device/K981434
Methodology: https://510kreport.com/methodology