FDA 510(k) Application Details - K192317

Device Classification Name	Full Field Digital,System,X-Ray,Mammographic   More FDA Info for this Device
510(K) Number	K192317
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	Lars Moring 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	08/26/2019
Decision Date	10/23/2020
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