Cleared Traditional

K163286 - ARTIS pheno

K163286 is an FDA 510(k) clearance for ARTIS pheno, manufactured by Siemens Medical Solution USA, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K163286 · Siemens Medical Solution USA, Inc. · Radiology device
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Mar 2017
Decision
107d
Days
Class 2
Risk

K163286 is an FDA 510(k) clearance for the ARTIS pheno. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solution USA, Inc. (Malvern, US). The FDA issued a Cleared decision on March 9, 2017 after a review of 107 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 Solution USA, Inc. devices

FDA 510(k) Submission Details - K163286

510(k) Number K163286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2016
Decision Date March 09, 2017
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
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 246
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