FDA 510(k) Application Details - K193262

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K193262
Device Name	System, X-Ray, Tomographic
Applicant	Agfa N.V. Septestraat 27 Mortsel B-2640 BE Other 510(k) Applications for this Company
Contact	Wim Govaerts Other 510(k) Applications for this Contact
Regulation Number	892.1740   More FDA Info for this Regulation Number
Classification Product Code	IZF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2019
Decision Date	03/09/2020
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