# K111243: Fujinon Ultrasonic Processor

- Pathway: 510(k) (Special)
- Applicant: Fujinon, Inc.
- Decided: May 16, 2011 after 13 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: 5 generations back to K822846 (1982). 24 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 32 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700, Fujinon, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K183433: FUJIFILM Ultrasonic Endoscope (2019), 2 descendants of its own
- K153206: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 (2016), 1 descendant of its own
- K221238: FUJIFILM Ultrasonic Endoscope EG-740UT (2022), 0 descendants of its own

## Indications for use
The ultrasonic processor (SU-8000) is intended to be used in combination with Fujinon/Fujifilm ultrasonic endoscope, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, recording and to aid in diagnosis during endoscopic evaluation.

Source page: https://510kreport.com/device/K111243
Methodology: https://510kreport.com/methodology