INTERWORKS

System, Image Processing, Radiological

AVREO, INC.

The following data is part of a premarket notification filed by Avreo, Inc. with the FDA for Interworks.

Pre-market Notification Details

• Device ID: K070755
• 510k Number: K070755
• Device Name: INTERWORKS
• Classification: System, Image Processing, Radiological
• Applicant: AVREO, INC. 4050 AZALEA DR. N. Charleston, SC 29405
• Contact: Nancy Butcher
• Correspondent: Nancy Butcher; AVREO, INC. 4050 AZALEA DR. N. Charleston, SC 29405
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-19
• Decision Date: 2007-05-08
• Summary: summary