Cleared Abbreviated

K162148 - Allura Xper R9

K162148 is an FDA 510(k) clearance for Allura Xper R9, manufactured by Philips Medical Systems Nethrlands BV. The device is a Class 2 Radiology device with product code OWB cleared through the Abbreviated 510(k) pathway after a 114-day FDA review.

K162148 · Philips Medical Systems Nethrlands BV · Radiology device
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Nov 2016
Decision
114d
Days
Class 2
Risk

K162148 is an FDA 510(k) clearance for the Allura Xper R9. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Philips Medical Systems Nethrlands BV (Best Noord-Brabant, NL). The FDA issued a Cleared decision on November 23, 2016 after a review of 114 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Philips Medical Systems Nethrlands BV devices

FDA 510(k) Submission Details - K162148

510(k) Number K162148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2016
Decision Date November 23, 2016
Days to Decision 114 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 107d · This submission: 114d
Pathway characteristics
Standards-based clearance path.

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 248
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