Cleared Traditional

K193326 - ARTIS Icono

K193326 is an FDA 510(k) clearance for ARTIS Icono, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K193326 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
136d
Days
Class 2
Risk

K193326 is an FDA 510(k) clearance for the ARTIS Icono. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on April 16, 2020 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K193326

510(k) Number K193326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2019
Decision Date April 16, 2020
Days to Decision 136 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 107d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 291
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K193326.
CFP-3131, CFP-2222
K201172 · Mx Imaging, Inc. · May 2020
Azurion R2.1
K200917 · Philips Medical Systems Nederland B.V. · May 2020
O-arm O2 Imaging System
K200074 · Medtronic, Inc. · Apr 2020
AS-10
K200887 · Canon, Inc. · Apr 2020
FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System
K200022 · Livermoretech, Inc. · Apr 2020
TrackX
K200360 · Track X Technology, LLC · Mar 2020