510(k) · Gastroenterology-Urology

EW10-EC02 Endoscopy Support Program

by FUJIFILM Corporation

EW10-EC02 Endoscopy Support Program is an AI-enabled medical device from FUJIFILM Corporation that the U.S. FDA cleared through 510(k) K230751 on December 15, 2023. Its lead review panel is Gastroenterology-Urology and its primary product code is QNP (Gastrointesinal Lesion Software Detection System).

See also FDA-cleared AI gastroenterology-urology devices in 2023, all FDA AI clearances in 2023, top gastroenterology-urology AI devices.

Key facts

Submission numberK230751
Pathway510(k)
Date of final decision
Company (FDA list)FUJIFILM Corporation
Lead review panelGastroenterology-Urology
Primary product codeQNP — Gastrointesinal Lesion Software Detection System
Applicant (openFDA)Fujifilm Corporation
Applicant locationAshigara Kami-Gun, JP
Device classClass 2
Regulation number21 CFR 876.1520
Decision codeSESE
Submission typeTraditional

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. EW10-EC02 Endoscopy Support Program went through this pathway (K230751).

openFDA lists it as a Class 2 device under 21 CFR 876.1520. Class II devices are moderate risk and are subject to general and special controls.

Product code QNP covers 20 devices on the FDA AI list. By decision date, this device is #8 of 20 under that code. FUJIFILM Corporation has 7 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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