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FDA 510(k) Application Details - K190457
Device Classification Name
System, Tomography, Computed, Emission
More FDA Info for this Device
510(K) Number
K190457
Device Name
System, Tomography, Computed, Emission
Applicant
Spectrum Dynamics Medical Ltd
22 Bareket St.
North Industrial Park. Caesarea 3079837 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
02/25/2019
Decision Date
07/12/2019
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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