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FDA 510(k) Application Details - K130224
Device Classification Name
System, X-Ray, Tomography, Computed
More FDA Info for this Device
510(K) Number
K130224
Device Name
System, X-Ray, Tomography, Computed
Applicant
IMRIS, INC.
100-1370 SONY PLACE
WINNIPEG, MB R3T 1N5 CA
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Contact
Daniel Biank
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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
01/29/2013
Decision Date
07/18/2013
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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