# K182825: FUJIFILM Ultrasonic Endoscope

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Feb 22, 2019 after 141 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894632 (1989). 50 ancestors in all.
No later device cites it as a predicate yet.
1 of 51 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121035: Fujinon/Fujifilm Ultrasonic Endoscope EB-530US, Fujifilm Medical System U.S.A., Inc. (2012) Summary page 4.

## Indications for use
EB-530US is intended for the observation, diagnosis, and endoscopic treatment of the trachea, bronchial tree and surrounding organs using ultrasonic images. It is used with a FUJIFILM ultrasonic processor, video processor, light source, other peripheral equipment and endoscopic accessories. It is not intended for use on children and infants.

Source page: https://510kreport.com/device/K182825
Methodology: https://510kreport.com/methodology