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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K213137
Device Name INTDose
Applicant
Carina Medical, LLC
1233 Litchfield Ln
Lexington,  KY  40513
Applicant Contact Xue Feng
Correspondent
Carina Medical, LLC
1233 Litchfield Ln
Lexington,  KY  40513
Correspondent Contact Xue Feng
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/27/2021
Decision Date 05/13/2022
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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