FDA 510(k) Application Details - K223484

Device Classification Name	Coil, Magnetic Resonance, Specialty   More FDA Info for this Device
510(K) Number	K223484
Device Name	Coil, Magnetic Resonance, Specialty
Applicant	Insight Medbotics Inc. 39 Charlton Avenue East Hamilton L8N 1Y3 CA Other 510(k) Applications for this Company
Contact	Paul Chipperton 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	11/18/2022
Decision Date	07/20/2023
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