FDA 510(k) Application Details - K211215

Device Classification Name	Full Field Digital,System,X-Ray,Mammographic   More FDA Info for this Device
510(K) Number	K211215
Device Name	Full Field Digital,System,X-Ray,Mammographic
Applicant	GE Healthcare 283 Rue de la MiniΦre Buc 78530 FR Other 510(k) Applications for this Company
Contact	Florian Akpakpa 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	04/23/2021
Decision Date	06/22/2021
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