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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 K223660
Device Name SaintView
Applicant
Inviz Corporation
307, Biomedical Components Center, Techno Park, 249
Chuam-Ro, Buk-Gu
Gwangju,  KR
Applicant Contact Priscilla Chung
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/06/2022
Decision Date 08/14/2023
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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