VANTAGE TITAN

System, Nuclear Magnetic Resonance Imaging

TOSHIBA MEDICAL SYSTEMS CORPORATION

The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Vantage Titan.

Pre-market Notification Details

• Device ID: K120638
• 510k Number: K120638
• Device Name: VANTAGE TITAN
• Classification: System, Nuclear Magnetic Resonance Imaging
• Applicant: TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DR Tustin, CA 92780
• Contact: Paul Biggins
• Correspondent: Paul Biggins; TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DR Tustin, CA 92780
• Product Code: LNH
• CFR Regulation Number: 892.1000 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-01
• Decision Date: 2012-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04987670102400	K120638	000