FDA 510(k) Application Details - K191495

Device Classification Name	System, X-Ray, Mammographic   More FDA Info for this Device
510(K) Number	K191495
Device Name	System, X-Ray, Mammographic
Applicant	FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun JP Other 510(k) Applications for this Company
Contact	Randy Vader 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	06/05/2019
Decision Date	07/03/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review