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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 K231852
Device Name BinkieRT
Applicant
Papricalab
219, 71, Ihwajang-Gil
Seoul,  KR 03087
Applicant Contact Sohyeon Woo
Correspondent
Gms Consulting
B612, 66, Cheongcho-Ro, Deogyang-Gu
Goyang-Si,  KR 10543
Correspondent Contact Jonghyum Kim
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/23/2023
Decision Date 11/15/2023
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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