FDA 510(k) Application Details - K052412

Device Classification Name	More FDA Info for this Device
510(K) Number	K052412
Device Name	INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
Applicant	GE HEALTHCARE 3000 N. GRANDVIEW BLVD WAUKESHA, WI 53188 US Other 510(k) Applications for this Company
Contact	LARRY A KROGER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/02/2005
Decision Date	09/16/2005
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	Y
Expedited Review