FDA 510(k) Application Details - K171487

Device Classification Name	Source, Brachytherapy, Radionuclide   More FDA Info for this Device
510(K) Number	K171487
Device Name	Source, Brachytherapy, Radionuclide
Applicant	C4 Imaging, LLC 196 West Ashland Street Doylestown, PA 18901 US Other 510(k) Applications for this Company
Contact	Andrew Bright Other 510(k) Applications for this Contact
Regulation Number	892.5730   More FDA Info for this Regulation Number
Classification Product Code	KXK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/22/2017
Decision Date	08/25/2017
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