# K214089: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Jun 3, 2022 after 157 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: 15 generations back to K935595 (1995). 117 ancestors in all.
No later device cites it as a predicate yet.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171207: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M, Fujifilm Medical Systems U.S.A, Inc. (2018) Summary page 4.

## Indications for use
FUJIFILM Ultrasonic Processor SP-900 The FUJIFILM ultrasonic processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation. Modes of Operation: B-mode FUJIFILM Ultrasonic Probe PB2020-M2 This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities. Modes of Operation: B-mode

Source page: https://510kreport.com/device/K214089
Methodology: https://510kreport.com/methodology