FDA 510(k) Application Details - K232392

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K232392
Device Name	System, X-Ray, Tomography, Computed
Applicant	4DMedical Limited Level 7, 700 Swanston Street Carlton 3053 AU Other 510(k) Applications for this Company
Contact	Nichole Murray 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	08/09/2023
Decision Date	11/16/2023
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