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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 K151924
Device Name Q-Rad Radiographic System with Auto-Tracker Option
Applicant
Quantum Medical Imaging Divison of Carestream
2002-B Orville Dr. N.
Ronkonkoma,  NY  11779
Applicant Contact MARK CAMIRAND
Correspondent
Delphi Medical Device Consulting, Inc.
5 Whitcomb Ave.
Ayer,  MA  01432
Correspondent Contact PAMELA PAPINEAU
Regulation Number892.1680
Classification Product Code
KPR  
Date Received07/13/2015
Decision Date 08/07/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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