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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 K072010
Device Name QUANTUM DIREX SYSTEM
Applicant
Quantum Medical Imaging, LLC
2002-B Orville Dr. N.
Ronkonkoma,  NY  11779
Applicant Contact MARK CAMIRAND
Correspondent
Underwriters Laboratories, Inc.
12 Laboratory Dr.
Research Triangel Park,  NC  27709
Correspondent Contact JEFF D RONGERO
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Code
MQB  
Date Received07/23/2007
Decision Date 08/07/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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