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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 K050033
Device Name LUCION
Applicant
Mevisys Co., Ltd.
30 Northport Rd.
Sound Beach,  NY  11789
Applicant Contact RICHARD LANZILLOTTO
Correspondent
Mevisys Co., Ltd.
30 Northport Rd.
Sound Beach,  NY  11789
Correspondent Contact RICHARD LANZILLOTTO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/07/2005
Decision Date 02/11/2005
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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