FDA 510(k) Application Details - K024171

Device Classification Name System, X-Ray, Tomography, Computed

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510(K) Number K024171
Device Name System, X-Ray, Tomography, Computed
Applicant VIDAR SYSTEMS CORP.
200 HOMER AVE.
ASHLAND, MA 01721 US
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Contact F. DAVID ROTHKOPF
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 12/18/2002
Decision Date 03/04/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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