FDA 510(k) Application Details - K182395

Device Classification Name	Dosimeter, Ionizing Radiation, Implanted   More FDA Info for this Device
510(K) Number	K182395
Device Name	Dosimeter, Ionizing Radiation, Implanted
Applicant	RadialDyne, LLC 10801 Hammerly Blvd. Suite 220 Houston, TX 77043 US Other 510(k) Applications for this Company
Contact	John 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	09/04/2018
Decision Date	03/22/2019
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