FDA 510(k) Application Details - K211720

Device Classification Name	Full Field Digital,System,X-Ray,Mammographic   More FDA Info for this Device
510(K) Number	K211720
Device Name	Full Field Digital,System,X-Ray,Mammographic
Applicant	Planmed Oy Sorvaajankatu 7 Helsinki 00880 FI Other 510(k) Applications for this Company
Contact	Niina Vuorikallas Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	MUE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/04/2021
Decision Date	07/18/2022
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