FDA 510(k) Application Details - K243316

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K243316
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Polarean, Inc. 2500 Meridian Parkway Suite 175 Durham, NC 27713 US Other 510(k) Applications for this Company
Contact	Neil Wadehra 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	10/22/2024
Decision Date	11/19/2024
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