FDA 510(k) Application Details - K223125

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K223125
Device Name	System, Image Processing, Radiological
Applicant	MediView XR, Inc. 10000 Cedar Ave STE# GCIC 2-153 Cleveland, OH 44106 US Other 510(k) Applications for this Company
Contact	Adam Cargill Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2022
Decision Date	07/13/2023
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