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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K102680
Device Name Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM
Applicant
Control-X Medical, Inc.
1755 Atlas St.
Columbus,  OH  43228
Applicant Contact LASZLO ADROVITZ
Correspondent
Control-X Medical, Inc.
1755 Atlas St.
Columbus,  OH  43228
Correspondent Contact LASZLO ADROVITZ
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/17/2010
Decision Date 10/22/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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