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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Digital Image Communications, Radiological
510(k) Number K974707
Device Name IMAGEQUEST
Applicant
Visual Med, Inc.
3695 Centre Cir. Dr.
Ft. Mill,  SC  29715
Correspondent
Visual Med, Inc.
3695 Centre Cir. Dr.
Ft. Mill,  SC  29715
Regulation Number892.2020
Classification Product Code
LMD  
Date Received12/16/1997
Decision Date 07/31/1998
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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