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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 K022692
Device Name VOXELPLUS PACS
Applicant
Mevisys Co., Ltd.
1100 Lakeview Blvd.
Denton,  TX  76208
Applicant Contact CARL ALLETTO
Correspondent
Mevisys Co., Ltd.
1100 Lakeview Blvd.
Denton,  TX  76208
Correspondent Contact CARL ALLETTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/13/2002
Decision Date 10/11/2002
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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