SpeqT

System, Imaging, Pulsed Echo, Ultrasonic

Signostics Limited

The following data is part of a premarket notification filed by Signostics Limited with the FDA for Speqt.

Pre-market Notification Details

• Device ID: K160420
• 510k Number: K160420
• Device Name: SpeqT
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: Signostics Limited 1284 South Road Clovelly Park, AU 5042
• Contact: Stewart Bartlett
• 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: 2016-02-16
• Decision Date: 2016-03-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09353278000670	K160420	000
09353278000663	K160420	000