MIRAGE

System, Image Processing, Radiological

SEGAMI CORP., INC.

The following data is part of a premarket notification filed by Segami Corp., Inc. with the FDA for Mirage.

Pre-market Notification Details

• Device ID: K972886
• 510k Number: K972886
• Device Name: MIRAGE
• Classification: System, Image Processing, Radiological
• Applicant: SEGAMI CORP., INC. 12624 GOLDEN OAK DR. Ellicott City, MD 21042
• Contact: Philippe Briandet
• Correspondent: Philippe Briandet; SEGAMI CORP., INC. 12624 GOLDEN OAK DR. Ellicott City, MD 21042
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-05
• Decision Date: 1997-10-01
• Summary: summary