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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 K200704
Device Name ZedView
Applicant
Lexi Co., Ltd.
2-11-1 Sugamo, Toshima-Ku
Tokyo,  JP 170-0002
Applicant Contact Takao Kusunoki
Correspondent
Lexi Co., Ltd.
2-11-1 Sugamo, Toshima-Ku
Tokyo,  JP 170-0002
Correspondent Contact Takao Kusunoki
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/18/2020
Decision Date 05/27/2021
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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