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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, Fluoroscopic, Image-Intensified
510(k) Number K191504
Device Name PowerDR
Applicant
Radiology Information Systems, Inc.
43676 Trade Center Pl., Suite 100
Dulles,  VA  20166
Applicant Contact Chen-Tai Ma
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1650
Classification Product Code
JAA  
Subsequent Product Code
MQB  
Date Received06/06/2019
Decision Date 08/16/2019
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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