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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 K211114
Device Name Will3D
Applicant
Hdx Will Corp.
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-Ro
Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Applicant Contact Kim In-Young
Correspondent
Hdx Will Corp.
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-Ro
Osong-Eup, Heungdeok-Gu
Cheongju-Si,  KR 28161
Correspondent Contact Kim In-Young
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/14/2021
Decision Date 12/15/2021
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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