OPAL-RAD

System, Image Processing, Radiological

VIZTEK, INC.

The following data is part of a premarket notification filed by Viztek, Inc. with the FDA for Opal-rad.

Pre-market Notification Details

• Device ID: K063337
• 510k Number: K063337
• Device Name: OPAL-RAD
• Classification: System, Image Processing, Radiological
• Applicant: VIZTEK, INC. 1600 MANCHESTER WAY Corinth, TX 76210
• Contact: Carl Alletto
• Correspondent: Carl Alletto; VIZTEK, INC. 1600 MANCHESTER WAY Corinth, TX 76210
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-06
• Decision Date: 2006-12-12
• Summary: summary