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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, Tomography, Computed
510(k) Number K130552
Device Name CT PULMONARY ANALYSIS
Applicant
Qi Imaging, LLC
1235 Radio Rd., Suite 110
Redwood City,  CA  94065
Applicant Contact RICHARD BALL
Correspondent
Qi Imaging, LLC
1235 Radio Rd., Suite 110
Redwood City,  CA  94065
Correspondent Contact RICHARD BALL
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/04/2013
Decision Date 01/13/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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