IMAGELINK

System, Image Processing, Radiological

COMPUTER PROGRAMS AND SYSTEMS, INC.

The following data is part of a premarket notification filed by Computer Programs And Systems, Inc. with the FDA for Imagelink.

Pre-market Notification Details

• Device ID: K112096
• 510k Number: K112096
• Device Name: IMAGELINK
• Classification: System, Image Processing, Radiological
• Applicant: COMPUTER PROGRAMS AND SYSTEMS, INC. 6600 WALL STREET Mobile, AL 36695 -4512
• Contact: Michael Hunt
• Correspondent: Michael Hunt; COMPUTER PROGRAMS AND SYSTEMS, INC. 6600 WALL STREET Mobile, AL 36695 -4512
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-22
• Decision Date: 2011-09-30
• Summary: summary