FDA 510(k) Application Details - K242731

Device Classification Name	More FDA Info for this Device
510(K) Number	K242731
Device Name	MasteRad MiniX Mobile Digital Imaging System (Mini-X)
Applicant	Medicatech USA Inc. 50 Maxwell Irvine, CA 92618 US Other 510(k) Applications for this Company
Contact	Theodor Gillebaard 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	09/10/2024
Decision Date	05/16/2025
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