Mobius3D

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 Mobius3d.

Pre-market Notification Details

• Device ID: K203669
• 510k Number: K203669
• Device Name: Mobius3D
• 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: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-16
• Decision Date: 2021-01-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850800006043	K203669	000