IDENTIFY

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 Identify.

Pre-market Notification Details

• Device ID: K192968
• 510k Number: K192968
• Device Name: IDENTIFY
• 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: 2019-10-23
• Decision Date: 2019-11-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00899475002592	K192968	000