Cleared Traditional

ALLURA XPER OR TABLE SERIES

K102005 · Philips Medical Systems North America, Inc. · Radiology

Aug 2010

Decision

25d

Days

Class 2

Risk

About This 510(k) Submission

K102005 is an FDA 510(k) clearance for the ALLURA XPER OR TABLE SERIES, a Interventional Fluoroscopic X-ray System (Class II — Special Controls, product code OWB), submitted by Philips Medical Systems North America, Inc. (Bothell, US). The FDA issued a Cleared decision on August 9, 2010, 25 days after receiving the submission on July 15, 2010. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K102005 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2010
Decision Date	August 09, 2010
Days to Decision	25 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