Cleared Traditional

3DXR

K243446 · GE Medical Systems SCS · Radiology

Feb 2025

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K243446 is an FDA 510(k) clearance for the 3DXR, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on February 25, 2025, 111 days after receiving the submission on November 6, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K243446 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 06, 2024
Decision Date	February 25, 2025
Days to Decision	111 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