FDA 510(k) Application Details - K201586

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K201586
Device Name	System, X-Ray, Tomography, Computed
Applicant	XACT Robotics Ltd. 8 Hatochen Street, PO Box 3097 Caesarea 3079861 IL Other 510(k) Applications for this Company
Contact	Chen Levin Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2020
Decision Date	07/09/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review