PROWIN

System, Image Processing, Radiological

MEDICAL TECHNOLOGIES INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Medical Technologies International, Inc. with the FDA for Prowin.

Pre-market Notification Details

• Device ID: K050376
• 510k Number: K050376
• Device Name: PROWIN
• Classification: System, Image Processing, Radiological
• Applicant: MEDICAL TECHNOLOGIES INTERNATIONAL, INC. BILTMORE TOWER 500 SOUTH GRAND AVENUE Los Angeles, CA 90071
• Contact: Marc Bozenan
• Correspondent: Marc Bozenan; MEDICAL TECHNOLOGIES INTERNATIONAL, INC. BILTMORE TOWER 500 SOUTH GRAND AVENUE Los Angeles, CA 90071
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-02-14
• Decision Date: 2005-04-07
• Summary: summary