FDA 510(k) Application Details - K203677

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K203677
Device Name	System, Image Processing, Radiological
Applicant	GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 US Other 510(k) Applications for this Company
Contact	Tracey Ortiz 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	12/17/2020
Decision Date	01/15/2021
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