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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 EAST 45TH STREET, 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
Recalls CDRH Recalls
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