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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 K120477
Device Name AEROSYNC FOR AERODR SYSTEM
Applicant
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Applicant Contact RESSELL MUNVES
Correspondent
Konica Minolta Medical & Graphic, Inc.
140 E. 45th St., 25th Floor
Two Grand Central Tower
New York,  NY  10017
Correspondent Contact RESSELL MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Date Received02/16/2012
Decision Date 04/09/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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