ALLURACLARITY XPER FD SERIES X-RAY SYSTEM

Interventional Fluoroscopic X-ray System

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Alluraclarity Xper Fd Series X-ray System.

Pre-market Notification Details

• Device ID: K130638
• 510k Number: K130638
• Device Name: ALLURACLARITY XPER FD SERIES X-RAY SYSTEM
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5694 Pc
• Contact: Klien Van Dam
• Correspondent: Klien Van Dam; PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5694 Pc
• Product Code: OWB
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-03-11
• Decision Date: 2013-06-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838059108	K130638	000
00884838059092	K130638	000
00884838059085	K130638	000
00884838059078	K130638	000
00884838059061	K130638	000
00884838059054	K130638	000
00884838059047	K130638	000
00884838059030	K130638	000