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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 K223842
Device Name DRX - Compass
Applicant
Carestream Health, Inc.
Building 7, No. 1510 Chuanqiao Road
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Applicant Contact Jessica DeRyke
Correspondent
Carestream Health, Inc.
Building 7, No. 1510 Chuanqiao Road
China (Shanghai) Pilot Free Trade Zone,  CN 201206
Correspondent Contact Jessica DeRyke
Regulation Number892.1680
Classification Product Code
KPR  
Date Received12/22/2022
Decision Date 01/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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