FDA 510(k) Application Details - K213081

Device Classification Name	System, X-Ray, Tomographic   More FDA Info for this Device
510(K) Number	K213081
Device Name	System, X-Ray, Tomographic
Applicant	General Medical Merate S.P.A Via Partigiani, 25 Seriate 24068 IT Other 510(k) Applications for this Company
Contact	Luca Bianchessi 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	09/23/2021
Decision Date	10/26/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review