FDA 510(k) Application Details - K223079

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K223079
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms, MI 48025 US Other 510(k) Applications for this Company
Contact	Rana El Hachem Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2022
Decision Date	10/28/2022
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