AUTOALIGN

System, Image Processing, Radiological

CORTECHS LABS, INC.

The following data is part of a premarket notification filed by Cortechs Labs, Inc. with the FDA for Autoalign.

Pre-market Notification Details

• Device ID: K021191
• 510k Number: K021191
• Device Name: AUTOALIGN
• Classification: System, Image Processing, Radiological
• Applicant: CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027
• Contact: Jeffrey M Anderson
• Correspondent: Jeffrey M Anderson; CORTECHS LABS, INC. 6 13TH ST. Charlestown, MA 02129 -2027
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-04-15
• Decision Date: 2002-07-12
• Summary: summary