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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K102327
Device Name CLEARVISION DR 7000F
Applicant
Jpi Healthcare Co, Ltd.
170-5 Guro-3 Dong, #608
Kuro-Gu
Seoul,  KR 152-847
Applicant Contact WILLIAM LITTLE
Correspondent
Jpi Healthcare Co, Ltd.
170-5 Guro-3 Dong, #608
Kuro-Gu
Seoul,  KR 152-847
Correspondent Contact WILLIAM LITTLE
Regulation Number892.1680
Classification Product Code
MQB  
Subsequent Product Code
KPR  
Date Received08/17/2010
Decision Date 04/13/2012
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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