Cleared Traditional

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2

K214089 · Fujifilm Corporation · Radiology

Jun 2022

Decision

157d

Days

Class 2

Risk

About This 510(k) Submission

K214089 is an FDA 510(k) clearance for the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2, a Endoscopic Ultrasound System, Gastroenterology-urology (Class II — Special Controls, product code ODG), submitted by Fujifilm Corporation (Ashigara Kami-Gun, JP). The FDA issued a Cleared decision on June 3, 2022, 157 days after receiving the submission on December 28, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 876.1500.

Submission Details

510(k) Number	K214089 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 2021
Decision Date	June 03, 2022
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	ODG — Endoscopic Ultrasound System, Gastroenterology-urology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1500
Definition	To Provide Ultrasonic Visualization Of Body Cavities That Can Be Accessed By Endoscope. For Reusable, Flexible Endoscopes In This Product Code, Validated Reprocessing Instructions And Reprocessing Validation Data Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).