Will3D

System, Image Processing, Radiological

HDX WILL CORP.

The following data is part of a premarket notification filed by Hdx Will Corp. with the FDA for Will3d.

Pre-market Notification Details

Device IDK211114
510k NumberK211114
Device Name:Will3D
ClassificationSystem, Image Processing, Radiological
Applicant HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
ContactKim In-young
CorrespondentKim In-young
HDX WILL CORP. #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongju-si,  KR 28161
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-14
Decision Date2021-12-15

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800005200298 K211114 000

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