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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K250170
Device Name PHAROS
Applicant
Brightonix Imaging
#B203, #409, Seongsu AK valley
76, Yeonmujang-gil, Seongdong-gu
Seoul,  KR 04784
Applicant Contact Radcheck Yang
Correspondent
510K FDA Inc.
156 E. Granada Blvd.
Ormond Beach,  FL  32176
Correspondent Contact Lee Strong
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/21/2025
Decision Date 08/15/2025
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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