FDA 510(k) Application Details - K150719

Device Classification Name	Dosimeter, Ionizing Radiation, Implanted   More FDA Info for this Device
510(K) Number	K150719
Device Name	Dosimeter, Ionizing Radiation, Implanted
Applicant	RadiaDyne, LLC 2313 W. Sam Houston Pkwy. N., Suite 107 Houston, TX 77043 US Other 510(k) Applications for this Company
Contact	John K. Isham Other 510(k) Applications for this Contact
Regulation Number	892.5050   More FDA Info for this Regulation Number
Classification Product Code	NZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2015
Decision Date	06/16/2015
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