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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 K024171
Device Name VIDAR BONE TRACK SYSTEM SOFTWARE
Applicant
Vidar Systems Corp.
200 Homer Ave.,
Ashland,  MA  01721
Applicant Contact F. DAVID ROTHKOPF
Correspondent
Vidar Systems Corp.
200 Homer Ave.,
Ashland,  MA  01721
Correspondent Contact F. DAVID ROTHKOPF
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
HWT  
Date Received12/18/2002
Decision Date 03/04/2003
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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