FDA 510(k) Application Details - K241440

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K241440
Device Name	System, X-Ray, Tomography, Computed
Applicant	Nano-X AI Ltd. Shlomo Shmeltzer Road 94 PO BOX 3486 Petah Tikva 4970602 IL Other 510(k) Applications for this Company
Contact	Neta Sherman 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	05/21/2024
Decision Date	08/19/2024
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