Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, 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 Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon.

Pre-market Notification Details

• Device ID: K192377
• 510k Number: K192377
• Device Name: Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-30
• Decision Date: 2020-02-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857235006044	K192377	000
00857235006037	K192377	000
00856100006141	K192377	000
00856100006134	K192377	000