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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 K945582
Device Name WITT BIOMEDICAL IMAGE III
Applicant
Witt Biomedical Corporation
295 N. Dr.,
Suite H
Melbourne,  FL  32934
Applicant Contact ERENCENE R WITT
Correspondent
Witt Biomedical Corporation
295 N. Dr.,
Suite H
Melbourne,  FL  32934
Correspondent Contact ERENCENE R WITT
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
IZI  
Date Received11/14/1994
Decision Date 06/19/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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