FDA 510(k) Application Details - K183332

Device Classification Name	System, Applicator, Radionuclide, Remote-Controlled   More FDA Info for this Device
510(K) Number	K183332
Device Name	System, Applicator, Radionuclide, Remote-Controlled
Applicant	BRAXX Biotech Co. Ltd 6F., No.10, Songde Rd., Xinyi Dist Taipei City 11076 TW Other 510(k) Applications for this Company
Contact	Judy Kao 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	12/03/2018
Decision Date	04/16/2019
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