510(k) · Radiology

EndoNaut

by Therenva SAS

EndoNaut is an AI-enabled medical device from Therenva SAS that the U.S. FDA cleared through 510(k) K212383 on August 31, 2021. Its lead review panel is Radiology and its primary product code is OWB (Interventional Fluoroscopic X-Ray System).

See also FDA-cleared AI radiology devices in 2021, all FDA AI clearances in 2021, top radiology AI devices.

Key facts

Submission numberK212383
Pathway510(k)
Date of final decision
Company (FDA list)Therenva SAS
Lead review panelRadiology
Primary product codeOWB — Interventional Fluoroscopic X-Ray System
Applicant (openFDA)Therenva Sas
Applicant locationRennes, FR
Device classClass 2
Regulation number21 CFR 892.1650
Decision codeSESE
Submission typeSpecial

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. EndoNaut went through this pathway (K212383).

openFDA lists it as a Class 2 device under 21 CFR 892.1650. Class II devices are moderate risk and are subject to general and special controls.

Product code OWB covers 15 devices on the FDA AI list. By decision date, this device is #2 of 15 under that code. Therenva SAS has 2 AI-enabled devices on the list, and the Radiology panel accounts for 1,230 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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