VERADIUS

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 Veradius.

Pre-market Notification Details

• Device ID: K133819
• 510k Number: K133819
• Device Name: VERADIUS
• Classification: Interventional Fluoroscopic X-ray System
• Applicant: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc
• Contact: Ruojuan Zhang
• Correspondent: Ruojuan Zhang; PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. VEENPLUIS 4-6 Best, NL 5684 Pc
• Product Code: OWB
• Subsequent Product Code: JAA
• Subsequent Product Code: OXO
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-16
• Decision Date: 2014-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838044302	K133819	000