FDA 510(k) Application Details - K183220

Device Classification Name	More FDA Info for this Device
510(K) Number	K183220
Device Name	OrthoScan TAU Mini C-Arm
Applicant	Orthoscan, Inc. 14555 N. 82nd St. Scottsdale, AZ 85260 US Other 510(k) Applications for this Company
Contact	Richard Westrich 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	11/20/2018
Decision Date	06/21/2019
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