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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 K111305
Device Name UNIVERSAL DIGITAL INTERFACE WIRELESS - UDI 1417W
Applicant
Meridian Medical Systems, LLC
325 Harris Dr.
Aurora,  OH  44202
Applicant Contact ARIEL MARCIANO
Correspondent
Meridian Medical Systems, LLC
325 Harris Dr.
Aurora,  OH  44202
Correspondent Contact ARIEL MARCIANO
Regulation Number892.1680
Classification Product Code
MQB  
Date Received05/09/2011
Decision Date 01/31/2012
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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