Afina

System, Image Management, Ophthalmic

NeuroVision Imaging, LLC

The following data is part of a premarket notification filed by Neurovision Imaging, Llc with the FDA for Afina.

Pre-market Notification Details

• Device ID: K181501
• 510k Number: K181501
• Device Name: Afina
• Classification: System, Image Management, Ophthalmic
• Applicant: NeuroVision Imaging, LLC 1395 Garden Highway, Suite 250 Sacramento, CA 95833
• Contact: Pepe Davis
• Correspondent: Pepe Davis; NeuroVision Imaging, LLC 1395 Garden Highway, Suite 250 Sacramento, CA 95833
• Product Code: NFJ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-06-07
• Decision Date: 2018-11-02
• Summary: summary