# K200850: Fujifilm Ultrasonic Processor

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Jul 6, 2020 after 97 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.
No later device cites it as a predicate yet.
1 of 27 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153206: Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1, Fujifilm Medical System U.S.A., Inc. (2016) Summary page 4.

## Indications for use
The FUJIFILM ultrasonic processors SU-1 PLATINUM and SU-1 are intended to be used in combination with FUJIFILM ultrasonic endoscope, Video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the trachea, bronchial tree and surrounding organs, or 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/K200850
Methodology: https://510kreport.com/methodology