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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K884268
Device Name VOXELSCOPE(TM)
Applicant
Dynamic Digital Displays, Inc.
3508 Market St. Suite 257
Philadelphia,  PA  19104
Applicant Contact DAVID A TALTON
Correspondent
Dynamic Digital Displays, Inc.
3508 Market St. Suite 257
Philadelphia,  PA  19104
Correspondent Contact DAVID A TALTON
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/11/1988
Decision Date 12/20/1988
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
Recalls CDRH Recalls
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