UNIQUE

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 Unique.

Pre-market Notification Details

• Device ID: K132705
• 510k Number: K132705
• Device Name: UNIQUE
• 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: 2013-08-29
• Decision Date: 2013-10-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857235006013	K132705	000