NEUROSCAPE

System, Image Processing, Radiological

OLEA MEDICAL

The following data is part of a premarket notification filed by Olea Medical with the FDA for Neuroscape.

Pre-market Notification Details

• Device ID: K083491
• 510k Number: K083491
• Device Name: NEUROSCAPE
• Classification: System, Image Processing, Radiological
• Applicant: OLEA MEDICAL 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Contact: Neal Kolber
• Correspondent: Neal Kolber; OLEA MEDICAL 1705 S. CAPITAL OF TEXAS HWY SUITE 500 Austin, TX 78746
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-11-25
• Decision Date: 2009-02-19
• Summary: summary