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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K212550
Device Name Hura CTP v1.0
Applicant
Hura Imaging, Inc.
23120 Park Sorrento
Calabasas,  CA  91302
Applicant Contact Danny Wang
Correspondent
Rook Quality Systems, Inc.
1155 Mount Vernon Hwy., Suite 800
Dunwoody,  GA  30338
Correspondent Contact Andrew Wu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/13/2021
Decision Date 11/08/2021
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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