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 Other 510(k) Applications for this Company
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