510(k) · Radiology

O-arm O2 Imaging System

by Medtronic Navigation, Inc

O-arm O2 Imaging System is an AI-enabled medical device from Medtronic Navigation, Inc that the U.S. FDA cleared through 510(k) K240465 on June 21, 2024. 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 2024, all FDA AI clearances in 2024, top radiology AI devices.

Key facts

Submission numberK240465
Pathway510(k)
Date of final decision
Company (FDA list)Medtronic Navigation, Inc
Lead review panelRadiology
Primary product codeOWB — Interventional Fluoroscopic X-Ray System
Applicant (openFDA)Medtronic Navigation, Inc.
Applicant locationBoxborough, MA, US
Device classClass 2
Regulation number21 CFR 892.1650
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. O-arm O2 Imaging System went through this pathway (K240465).

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 #6 of 15 under that code. Medtronic Navigation, Inc has 3 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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