Uscan

System, Imaging, Pulsed Echo, Ultrasonic

EchoNous, Inc.

The following data is part of a premarket notification filed by Echonous, Inc. with the FDA for Uscan.

Pre-market Notification Details

• Device ID: K181574
• 510k Number: K181574
• Device Name: Uscan
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: EchoNous, Inc. 8310 154th Ave NE Building B, Suite 200 Redmond, VA 98052
• Contact: Trish Liau
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2018-06-15
• Decision Date: 2018-07-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09353278000199	K181574	000
09353278000526	K181574	000
09353278000540	K181574	000
09353278000533	K181574	000
09353278000236	K181574	000
09353278000076	K181574	000
09353278000205	K181574	000
09353278000052	K181574	000
09353278000069	K181574	000
09353278000601	K181574	000