FDA 510(k) Application Details - K180069

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K180069
Device Name	System, Applicator, Radionuclide, Remote-Controlled
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	892.5700   More FDA Info for this Regulation Number
Classification Product Code	JAQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/09/2018
Decision Date	04/27/2018
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