# K171207: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Jan 11, 2018 after 261 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: 14 generations back to K935595 (1995). 116 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 118 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130058: Endoscopic Ultrasound Center EU-Y0008, Olympus Medical Systems Corp. (2013) Summary page 4.

## Most influential descendants
- K214089: FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 (2022), 0 descendants of its own

## Indications for use
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. PB2020-M: 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.

Source page: https://510kreport.com/device/K171207
Methodology: https://510kreport.com/methodology