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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Film, Radiographic
510(k) Number K954200
Device Name VOXGRAM
Applicant
Voxel
26081 Merit Cir., #117
Laguna Hills,  CA  92653
Applicant Contact MURRAY RUDIN
Correspondent
Voxel
26081 Merit Cir., #117
Laguna Hills,  CA  92653
Correspondent Contact MURRAY RUDIN
Regulation Number892.1840
Classification Product Code
IWZ  
Date Received09/06/1995
Decision Date 09/29/1995
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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