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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K142708
Device Name VERADIUS UNITY
Applicant
Philips Medical Systems Nethrlands BV
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Applicant Contact Jeanette Becker
Correspondent
Philips Medical Systems Nethrlands BV
Veenpluis 4-6
Best Noord-Brabant,  NL 5684 pc
Correspondent Contact Jeanette Becker
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received09/22/2014
Decision Date 10/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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