FDA 510(k) Application Details - K040782

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

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510(K) Number K040782
Device Name System, X-Ray, Tomography, Computed
Applicant IMAGE ANALYSIS, INC.
1380 BURKESVILLE ST.
COLUMBIA, KY 42728 US
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Contact BEN ARNOLD
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Regulation Number 892.1750

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Classification Product Code JAK
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Date Received 03/26/2004
Decision Date 07/13/2004
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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