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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 K123499
Device Name AEROPILOT
Applicant
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK,  NY  10017
Applicant Contact RUSSELL MUNVES
Correspondent
KONICA MINOLTA MEDICAL & GRAPHIC, INC.
140 EAST 45TH ST., 25TH FLOOR
TWO GRAND CENTRAL TOWER
NEW YORK,  NY  10017
Correspondent Contact RUSSELL MUNVES
Regulation Number892.1680
Classification Product Code
MQB  
Date Received11/13/2012
Decision Date 12/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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