Halcyon

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 Halcyon.

Pre-market Notification Details

• Device ID: K181032
• 510k Number: K181032
• Device Name: Halcyon
• Classification: Accelerator, Linear, Medical
• Applicant: Varian Medical Systems Inc. 911 Hansen Way Palo Alto, CA 94304
• Contact: Peter J. Coronado
• Correspondent: Peter J. Coronado; Varian Medical Systems Inc. 911 Hansen Way Palo Alto, CA 94304
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-04-18
• Decision Date: 2018-05-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857235006020	K181032	000