Cleared Traditional

ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)

K241572 · Siemens Medical Solutions USA, Inc. · Radiology

Oct 2024

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K241572 is an FDA 510(k) clearance for the ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A), a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on October 22, 2024, 144 days after receiving the submission on May 31, 2024. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K241572 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 31, 2024
Decision Date	October 22, 2024
Days to Decision	144 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