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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K211317
Device Name CRUXVIEW
Applicant
Cruxell Corp.
405, Migun Techno World Ii, 187, Techno 2-Ro Yuseong-Gu
Daejeon,  KR 34025
Applicant Contact Boeun Bang
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.1800
Classification Product Code
MUH  
Date Received04/30/2021
Decision Date 07/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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