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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 K221000
Device Name ON3D
Applicant
3D Ons, Inc.
18, Eonju-Ro 171-Gil
Gangnam-Gu,  KR 06023
Applicant Contact Jeong Rae Cho
Correspondent
KMC, Inc.
Rm. # 1709, 123, Digital-Ro 26-Gil, Guro-Gu
Seoul,  KR 08390
Correspondent Contact DongHa Lee
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/04/2022
Decision Date 05/23/2022
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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