FDA 510(k) Application Details - K241567

Device Classification Name	More FDA Info for this Device
510(K) Number	K241567
Device Name	MC2 Portable X-ray System
Applicant	Oxos Medical 1100 Peachtree St NE Ste 700 Atlanta, GA 30309 US Other 510(k) Applications for this Company
Contact	Dhruv Vishwakarma Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2024
Decision Date	12/06/2024
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