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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 Building 7F, 61, Yangwha-ro, Mapo-gu, Seoul,
Republic of Korea
Seoul,  KR 04037
Applicant Contact Hye-ri Choi
Correspondent
Medipixel, Inc.
Dooam Building 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
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