IMAGEGRID

System, Image Processing, Radiological

CANDELIS, INC.

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

Pre-market Notification Details

• Device ID: K080333
• 510k Number: K080333
• Device Name: IMAGEGRID
• Classification: System, Image Processing, Radiological
• Applicant: CANDELIS, INC. 1600 MANCHESTER WAY Corinth, TX 76210
• Contact: Carl Alletto
• Correspondent: Ned Devine; UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2008-02-07
• Decision Date: 2008-02-22
• Summary: summary