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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K133524
Device Name PVMED DDR 2430T
Applicant
Portavision Medical, LLC
5401 Cocos Plumosas Dr.
Kenner,  LA  70065
Applicant Contact TERRY ANCAR
Correspondent
Portavision Medical, LLC
5401 Cocos Plumosas Dr.
Kenner,  LA  70065
Correspondent Contact TERRY ANCAR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/15/2013
Decision Date 04/16/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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