SVIEW

System, Image Processing, Radiological

MRI CARDIAC SERVICES, INCORPORATED

The following data is part of a premarket notification filed by Mri Cardiac Services, Incorporated with the FDA for Sview.

Pre-market Notification Details

• Device ID: K060840
• 510k Number: K060840
• Device Name: SVIEW
• Classification: System, Image Processing, Radiological
• Applicant: MRI CARDIAC SERVICES, INCORPORATED 8 WEST THIRD ST. SUITE M9 Winston-salem, NC 27101
• Contact: S. Scott Huber
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2006-03-28
• Decision Date: 2006-04-07
• Summary: summary