Cleared Traditional

K130638 - ALLURACLARITY XPER FD SERIES X-RAY SYSTEM

K130638 is an FDA 510(k) clearance for ALLURACLARITY XPER FD SERIES X-RAY SYSTEM, manufactured by Philips Medical Systems Nederland B.V.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K130638 · Philips Medical Systems Nederland B.V. · Radiology device
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Jun 2013
Decision
109d
Days
Class 2
Risk

K130638 is an FDA 510(k) clearance for the ALLURACLARITY XPER FD SERIES X-RAY SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems Nederland B.V. (Best, NL). The FDA issued a Cleared decision on June 28, 2013 after a review of 109 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 Philips Medical Systems Nederland B.V. devices

FDA 510(k) Submission Details - K130638

510(k) Number K130638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date June 28, 2013
Days to Decision 109 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
2d slower than avg
Panel avg: 107d · This submission: 109d
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 293
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K130638.
STENTBOOST REL. 4
K132305 · Philips Medical Systems Nederland B.V. · Oct 2013
XPERCT REL. 3
K130893 · Philips Medical Systems Nederland B.V. · Sep 2013
XPERGUIDE
K131263 · Philips Medical Systems Nederland B.V. · Jul 2013
ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
K122644 · Siemens Medical Solutions USA, Inc. · May 2013
ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1
K121772 · Philips Medical Systems Nederland B.V. · Mar 2013
ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
K123529 · Siemens Medical Solutions USA, Inc. · Feb 2013