# K063847: Fujinon Ultrasonic Endoscope and Processor, Models EG-530UR, EG-530UT and SU-700

- Pathway: 510(k) (Traditional)
- Applicant: Fujinon, Inc.
- Decided: Mar 1, 2007 after 64 days
- Product code: FDS (Gastroscope And Accessories, Flexible/Rigid)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K822846 (1982). 23 ancestors in all.
8 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)
- K013640: EG-3630UR, Ultrasund Video Gastroscope, Pentax Precision Instrument Corp. (2002)
- K051541: GF-UE160-AL5 Ultrasound Endoscope, Olympus America, Inc. (2005) Summary page 2.
- K994026: Eub-6000 Ultrasound Diagnostic Scanner, Hitachi Medical Corp. of America (2000) Summary page 2.
- K011252: Eub-6000 Diagnostic Ultrasound Scanner SP-711 Sonoprobe System, Hitachi Medical Corp. (2001)

## Most influential descendants
- 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
- 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

## Recalls of this device
- Feb 17, 2017 · Class II · Z-2706-2017: Fujifilm is recalling multiple endoscopes after a retrospective review.

## Indications for use
The EG-530UR and EG-530UT ultrasonic endoscopes are intended to be used with the SU-7000 ultrasound processor. The system is used for the observation and diagnosis of the upper digestive tract (including the esophagus, stomach, duodenum, and underlying areas), as well as observation and diagnosis of submucosal and peripheral organs using ultrasonic images, and endoscopic treatment.

Source page: https://510kreport.com/device/K063847
Methodology: https://510kreport.com/methodology