Exo Iris

System, Imaging, Pulsed Doppler, Ultrasonic

Exo Imaging Inc.

The following data is part of a premarket notification filed by Exo Imaging Inc. with the FDA for Exo Iris.

Pre-market Notification Details

• Device ID: K211527
• 510k Number: K211527
• Device Name: Exo Iris
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: Exo Imaging Inc. 3600 Bridge Parkway Suite 102 Redwood City, CA 94065
• Contact: Antoanela Gomard
• Correspondent: Antoanela Gomard; Exo Imaging Inc. 3600 Bridge Parkway Suite 102 Redwood City, CA 94065
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-05-17
• Decision Date: 2021-08-20