NAVIGATOR

Accelerator, Linear, Medical

NOMOS CORP.

The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Navigator.

Pre-market Notification Details

• Device ID: K042875
• 510k Number: K042875
• Device Name: NAVIGATOR
• Classification: Accelerator, Linear, Medical
• Applicant: NOMOS CORP. 200 WEST KENSINGER DR. Cranberry Township, PA 16066
• Contact: Leigh Spotten
• Correspondent: Leigh Spotten; NOMOS CORP. 200 WEST KENSINGER DR. Cranberry Township, PA 16066
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-10-18
• Decision Date: 2005-07-01
• Summary: summary