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FDA 510(k) Application Details - K161740
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K161740
Device Name
System, Tomography, Computed, Emission
Applicant
Spectrum Dynamics Medical Ltd
22 Bareket St
Caesarea 3088900 IL
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Contact
Igor Naroditsky
Other 510(k) Applications for this Contact
Regulation Number
892.1200
More FDA Info for this Regulation Number
Classification Product Code
KPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/24/2016
Decision Date
11/04/2016
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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