LUCION

System, Image Processing, Radiological

MEVISYS CO. LTD

The following data is part of a premarket notification filed by Mevisys Co. Ltd with the FDA for Lucion.

Pre-market Notification Details

• Device ID: K050033
• 510k Number: K050033
• Device Name: LUCION
• Classification: System, Image Processing, Radiological
• Applicant: MEVISYS CO. LTD 30 NORTHPORT ROAD Sound Beach, NY 11789 -1734
• Contact: Richard Lanzillotto
• Correspondent: Richard Lanzillotto; MEVISYS CO. LTD 30 NORTHPORT ROAD Sound Beach, NY 11789 -1734
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-07
• Decision Date: 2005-02-11
• Summary: summary