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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K222036
Device Name MPXA-2000
Applicant
Medipixel, Inc.
Dooam Bldg. 7f, 61, Yangwha-Ro, Mapo-Gu, Seoul,
Republic Of Korea
Seoul,  KR 04037
Applicant Contact Hye-ri Choi
Correspondent
Medipixel, Inc.
Dooam Bldg. 7f, 61, Yangwha-Ro, Mapo-Gu, Seoul,
Republic Of Korea
Seoul,  KR 04037
Correspondent Contact Hye-ri Choi
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/11/2022
Decision Date 03/22/2023
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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