Cleared Traditional

O-arm O2 Imaging System

K240465 · Medtronic Navigation, Inc. · Radiology

Jun 2024

Decision

126d

Days

Class 2

Risk

About This 510(k) Submission

K240465 is an FDA 510(k) clearance for the O-arm O2 Imaging System, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Medtronic Navigation, Inc. (Boxborough, US). The FDA issued a Cleared decision on June 21, 2024, 126 days after receiving the submission on February 16, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K240465 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2024
Decision Date	June 21, 2024
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OWB — Interventional Fluoroscopic X-ray System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1650
Definition	Interventional Fluoroscopy