FDA 510(k) Application Details - K201103

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K201103
Device Name	System, Image Processing, Radiological
Applicant	GE Healthcare 4 Hayozma Street Tirat Hacarmel 30200 IL Other 510(k) Applications for this Company
Contact	Alexandra Lifshits Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2020
Decision Date	09/25/2020
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