VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS

System, Applicator, Radionuclide, Remote-controlled

VARIAN MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Varian Medical Systems with the FDA for Varian Intracavitary Brachytherapy Applicators.

Pre-market Notification Details

• Device ID: K033371
• 510k Number: K033371
• Device Name: VARIAN INTRACAVITARY BRACHYTHERAPY APPLICATORS
• Classification: System, Applicator, Radionuclide, Remote-controlled
• Applicant: VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129
• Contact: Vy Tran
• Correspondent: Vy Tran; VARIAN MEDICAL SYSTEMS 3100 HANSEN WAY M/S E-110 Palo Alto, CA 94304 -1129
• Product Code: JAQ
• CFR Regulation Number: 892.5700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-10-21
• Decision Date: 2003-12-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00816389029057	K033371	000
00816389022164	K033371	000
00816389022188	K033371	000
00816389022201	K033371	000
00816389022218	K033371	000
00816389022225	K033371	000
00816389022232	K033371	000
00816389022249	K033371	000
00816389022324	K033371	000
00816389022966	K033371	000
00816389022973	K033371	000
00816389022980	K033371	000
00816389022997	K033371	000
00816389023000	K033371	000
00816389023017	K033371	000
00816389023024	K033371	000
00816389023031	K033371	000
00816389023048	K033371	000
00816389022133	K033371	000
00816389022126	K033371	000
10816389027142	K033371	000
00816389027916	K033371	000
00816389021839	K033371	000
00816389021907	K033371	000
00816389021914	K033371	000
00816389021921	K033371	000
00816389021938	K033371	000
00816389021969	K033371	000
00816389022010	K033371	000
00816389022041	K033371	000
00816389022058	K033371	000
00816389022065	K033371	000
00816389022072	K033371	000
00816389022089	K033371	000
00816389022096	K033371	000
00816389022102	K033371	000
00816389022119	K033371	000
00816389023055	K033371	000
00816389023062	K033371	000
00816389023079	K033371	000
00816389023390	K033371	000
00816389023406	K033371	000
00816389023420	K033371	000
00816389023437	K033371	000
00816389023451	K033371	000
00816389023482	K033371	000
00816389023505	K033371	000
00816389023512	K033371	000
00816389023543	K033371	000
00816389023574	K033371	000
00816389023581	K033371	000
00816389023598	K033371	000
00816389023611	K033371	000
00816389023628	K033371	000
00816389023635	K033371	000
00816389024571	K033371	000
00816389024724	K033371	000
00816389023383	K033371	000
00816389023376	K033371	000
00816389023086	K033371	000
00816389023093	K033371	000
00816389023109	K033371	000
00816389023116	K033371	000
00816389023123	K033371	000
00816389023130	K033371	000
00816389023147	K033371	000
00816389023154	K033371	000
00816389023185	K033371	000
00816389023215	K033371	000
00816389023291	K033371	000
00816389023307	K033371	000
00816389023321	K033371	000
00816389023338	K033371	000
00816389023345	K033371	000
00816389023352	K033371	000
00816389023369	K033371	000
00816389025271	K033371	000