INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)

Accelerator, Linear, Medical

VARIAN MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Varian Medical Systems, Inc. with the FDA for Integrated Collimator Verification And Interlock System (icvi).

Pre-market Notification Details

• Device ID: K123788
• 510k Number: K123788
• Device Name: INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI)
• Classification: Accelerator, Linear, Medical
• Applicant: VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304
• Contact: Peter J Coronado
• Correspondent: Peter J Coronado; VARIAN MEDICAL SYSTEMS, INC. 3100 HANSEN WAY Palo Alto, CA 94304
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-10
• Decision Date: 2013-01-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00899475002271	K123788	000