FDA 510(k) Application Details - K203509

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K203509
Device Name	System, X-Ray, Mammographic
Applicant	IMS Giotto S.p.A. VIA Sagittario, 5 Sasso Marconi 40037 IT Other 510(k) Applications for this Company
Contact	Antonella Rossi Other 510(k) Applications for this Contact
Regulation Number	892.1710   More FDA Info for this Regulation Number
Classification Product Code	IZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/2020
Decision Date	07/14/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review