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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 K151465
Device Name AeroDR SYSTEM 2
Applicant
Konica Minolta, Inc.
1 Sakura-Machi
Hino-Shi,  JP 191-8511
Applicant Contact SHIGEYUKI KOJIMA
Correspondent
Storch Amini & Munves PC
140 E. 45th St.
25th Floor
New York,  NY  10017
Correspondent Contact RUSSELL D MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
LLZ  
Date Received06/01/2015
Decision Date 06/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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