FDA 510(k) Application Details - K173247

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K173247
Device Name	System, Image Processing, Radiological
Applicant	Ortho Kinematics, Inc 110 Wild Basin Road, Suite 250 Austin, TX 78746 US Other 510(k) Applications for this Company
Contact	Adam Dietz Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/06/2017
Decision Date	11/08/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review