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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, Stationary
510(k) Number K213057
Device Name ExamVue Duo
Applicant
Jpi Healthcare Co, Ltd.
608-Ho, 28, Digital-Ro 33-Gil, Guro-Gu
Seoul,  KR 08377
Applicant Contact Sam Kang
Correspondent
Jpi Healthcare Solutions, Inc.
52 Newtown Plz.
Plainview,  NY  11803
Correspondent Contact William Little
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/22/2021
Decision Date 02/18/2022
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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