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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 Place, Ste 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
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