FDA 510(k) Application Details - K223378

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K223378
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	GE Healthcare Coils (USA Instruments, Inc.) 1515 Danner Drive Aurora, OH 44202 US Other 510(k) Applications for this Company
Contact	Lauren Ross Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	MOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2022
Decision Date	01/03/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review