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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K921381
Device Name MEDGRAPHIX INTL VR 1000 SERIES
Applicant
Medgraphix Intl.
1429 County Line Rd.
Rosemont,  PA  19010
Applicant Contact JOHN DIMARCO
Correspondent
Medgraphix Intl.
1429 County Line Rd.
Rosemont,  PA  19010
Correspondent Contact JOHN DIMARCO
Regulation Number892.2040
Classification Product Code
LMC  
Date Received03/23/1992
Decision Date 11/02/1992
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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