# K181763: FUJIFILM Ultrasonic Endoscope

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Jul 27, 2018 after 24 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K822846 (1982). 26 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120446: Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2, Fujinon, Inc. (2012) Summary page 4.

## Most influential descendants
- K183433: FUJIFILM Ultrasonic Endoscope (2019), 2 descendants of its own
- K221238: FUJIFILM Ultrasonic Endoscope EG-740UT (2022), 0 descendants of its own
- K221952: Endoscope Model EG-580UT and Endoscope Model EG-580UR (2022), 0 descendants of its own

## Indications for use
EG-530UT2 and EG-530UR2 are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. The product is intended to be used with a Fujifilm ultrasonic processor. This product is not intended for use on children and infants.

Source page: https://510kreport.com/device/K181763
Methodology: https://510kreport.com/methodology