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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 K172803
Device Name Infinitt PACS 7.0
Infinitt Healthcare Co.,Ltd.
12FI Daerung Post Tower III, 27 Digital-ro 34-gil
Seoul,  KR 08378
Applicant Contact Sang Wook Cho
OTech Inc.
8317 Belew Drive
McKinney,  TX  75071
Correspondent Contact Carl Alletto
Regulation Number892.2050
Classification Product Code
Date Received09/18/2017
Decision Date 10/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No