# K183433: FUJIFILM Ultrasonic Endoscope

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Sep 5, 2019 after 268 days
- Product code: ODG (Endoscopic Ultrasound System, Gastroenterology-Urology)
- 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: 8 generations back to K822846 (1982). 27 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K181763: FUJIFILM Ultrasonic Endoscope, Fujifilm Corporation (2018) Summary page 4.

## Most influential descendants
- 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
FUJIFILM Ultrasonic Endoscopes EG-580UT and EG-580UR are intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis, and endoscopic treatment. These products are intended to be used with a FUJIFILM ultrasonic processor. These products are not intended for use on children and infants.

Source page: https://510kreport.com/device/K183433
Methodology: https://510kreport.com/methodology