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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 K222854
Device Name iTFlow
Applicant
Cardio Flow Design, Inc.
22-3 Ichibancho, Chiyoda-Ku
Tokyo,  JP 1020082
Applicant Contact Teruyasu Nishino
Correspondent
Cardio Flow Design, Inc.
22-3 Ichibancho, Chiyoda-Ku
Tokyo,  JP 1020082
Correspondent Contact Teruyasu Nishino
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/21/2022
Decision Date 05/12/2023
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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