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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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More FDA Info for this Product Code
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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