ULTRAVISUAL

System, Image Processing, Radiological

EMAGEON UV, INC.

The following data is part of a premarket notification filed by Emageon Uv, Inc. with the FDA for Ultravisual.

Pre-market Notification Details

• Device ID: K042008
• 510k Number: K042008
• Device Name: ULTRAVISUAL
• Classification: System, Image Processing, Radiological
• Applicant: EMAGEON UV, INC. 131 W. WILSON STREET, STE.700 Madison, WI 53703 -3243
• Contact: Inger Couture
• Correspondent: Laura Danielson; TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-07-26
• Decision Date: 2004-09-03
• Summary: summary