FDA 510(k) Application Details - K170946

Device Classification Name	More FDA Info for this Device
510(K) Number	K170946
Device Name	Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
Applicant	Skanray Technologies Private Limited Plot 15-17 Hebbal Industrial Area Mysore 570016 IN Other 510(k) Applications for this Company
Contact	Mahadevan J. 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	03/30/2017
Decision Date	11/24/2017
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