ZedView

System, Image Processing, Radiological

Lexi Co., Ltd.

The following data is part of a premarket notification filed by Lexi Co., Ltd. with the FDA for Zedview.

Pre-market Notification Details

Device IDK200704
510k NumberK200704
Device Name:ZedView
ClassificationSystem, Image Processing, Radiological
Applicant Lexi Co., Ltd. 2-11-1 Sugamo, Toshima-Ku Tokyo,  JP 170-0002
ContactTakao Kusunoki
CorrespondentTakao Kusunoki
Lexi Co., Ltd. 2-11-1 Sugamo, Toshima-Ku Tokyo,  JP 170-0002
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-18
Decision Date2021-05-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
14573443600029 K200704 000

Trademark Results [ZedView]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZEDVIEW
ZEDVIEW
87736895 not registered Live/Pending
LEXI Co., Ltd.
2017-12-28

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