CORONIS 5MP MAMMO SL, MODEL MDMG 6121

System, Image Processing, Radiological

BARCOVIEW, MEDICAL IMAGING SYSTEMS

The following data is part of a premarket notification filed by Barcoview, Medical Imaging Systems with the FDA for Coronis 5mp Mammo Sl, Model Mdmg 6121.

Pre-market Notification Details

• Device ID: K081109
• 510k Number: K081109
• Device Name: CORONIS 5MP MAMMO SL, MODEL MDMG 6121
• Classification: System, Image Processing, Radiological
• Applicant: BARCOVIEW, MEDICAL IMAGING SYSTEMS 35 PRESIDENT KENNEDYPARK Kortrijk, BE B-8500
• Contact: Neil Phillips
• Correspondent: Jeff D Rongero; UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-04-18
• Decision Date: 2008-05-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05415334001480	K081109	000