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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 K211059
Device Name CereFlow™ V1.2
Applicant
Translational Mri, LLC
3200 S Sepulveda Blvd.
Suite K 30
Los Angeles,  CA  90034
Applicant Contact Zhihai Ricky Xiang
Correspondent
Rook Quality Systems Taiwan Branch
Office 802, # 502, Sec 2, Ren’Ai Rd., Linkou District
New Taipei City,  TW 24
Correspondent Contact Andrew Wu
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/09/2021
Decision Date 03/31/2023
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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