VISIA

System, Image Processing, Radiological

MEVIS MEDICAL SOLUTIONS AG

The following data is part of a premarket notification filed by Mevis Medical Solutions Ag with the FDA for Visia.

Pre-market Notification Details

• Device ID: K120207
• 510k Number: K120207
• Device Name: VISIA
• Classification: System, Image Processing, Radiological
• Applicant: MEVIS MEDICAL SOLUTIONS AG N27 W24075 PAUL COURT SUITE 100 Pewaukee, WI 53072
• Contact: Thomas E Tynes
• Correspondent: Thomas E Tynes; MEVIS MEDICAL SOLUTIONS AG N27 W24075 PAUL COURT SUITE 100 Pewaukee, WI 53072
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-24
• Decision Date: 2012-04-23
• Summary: summary