BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6

Accelerator, Linear, Medical

NOMOS CORP.

The following data is part of a premarket notification filed by Nomos Corp. with the FDA for Bat Ultrasound Localization And Positioning System, Version 6.

Pre-market Notification Details

• Device ID: K070611
• 510k Number: K070611
• Device Name: BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
• Classification: Accelerator, Linear, Medical
• Applicant: NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 Cranberry Township, PA 16066
• Contact: Marita Brust
• Correspondent: Marita Brust; NOMOS CORP. 200 WEST KENSINGER DR. SUITE 100 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: 2007-03-05
• Decision Date: 2007-07-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00852656007076	K070611	000
00852656007021	K070611	000