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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K963936
Device Name ACCESSPOINT, MED E-MAIL, DICOM READER
Applicant
BIOSOUND, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Applicant Contact WAYNE NETHERCUTT
Correspondent
BIOSOUND, INC.
8000 CASTLEWAY DR.
INDIANAPOLIS,  IN  46250
Correspondent Contact WAYNE NETHERCUTT
Regulation Number892.2010
Classification Product Code
LMB  
Subsequent Product Code
IYO  
Date Received10/01/1996
Decision Date 03/31/1997
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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