FDA 510(k) Application Details - K193293

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K193293
Device Name	System, X-Ray, Tomography, Computed
Applicant	4Dx Limited Level 5 Suite 3, 468 St Kilda Rd Melbourne 3004 AU Other 510(k) Applications for this Company
Contact	Terrence Thiel 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	11/27/2019
Decision Date	05/14/2020
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