FDA 510(k) Application Details - K243452

Device Classification Name	More FDA Info for this Device
510(K) Number	K243452
Device Name	Orthoscan VERSA Mini C-Arm
Applicant	Ziehm-Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 US Other 510(k) Applications for this Company
Contact	Kevin Bridgman Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/07/2024
Decision Date	01/14/2025
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