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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 K031372
Device Name PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION
Applicant
Maxxvision, LLC
3014 NE 21st Way
Gainesville,  FL  32609
Applicant Contact JAMES K WALKER
Correspondent
Maxxvision, LLC
3014 NE 21st Way
Gainesville,  FL  32609
Correspondent Contact JAMES K WALKER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/30/2003
Decision Date 07/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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