FDA 510(k) Application Details - K213465

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K213465
Device Name	System, X-Ray, Tomography, Computed
Applicant	Arineta Ltd. 15 Halamish Street Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Tanya Shalem 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	10/28/2021
Decision Date	12/02/2022
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