FDA 510(k) Application Details - K244054

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K244054
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Quality Electrodynamics 6655 Beta Drive Ste 100 Mayfield Village, OH 44122 US Other 510(k) Applications for this Company
Contact	JoVanna Boudreaux 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	12/31/2024
Decision Date	02/28/2025
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