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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 K193574
Device Name Q-Rad System
Applicant
Carestream Health, Inc.
Bldg. 7, # 1510 Chuanqiao Rd.
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Applicant Contact Carolyn L Wagner
Correspondent
Carestream Health, Inc.
Bldg. 7, # 1510 Chuanqiao Rd.
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Correspondent Contact Carolyn L Wagner
Regulation Number892.1680
Classification Product Code
KPR  
Subsequent Product Codes
LLZ   MQB  
Date Received12/23/2019
Decision Date 01/22/2020
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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