FIBROSCAN

System, Imaging, Pulsed Echo, Ultrasonic

ECHOSENS

The following data is part of a premarket notification filed by Echosens with the FDA for Fibroscan.

Pre-market Notification Details

• Device ID: K123806
• 510k Number: K123806
• Device Name: FIBROSCAN
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: ECHOSENS 990 WASHINGTON STREET, STE #204 Dedham, MA 02026
• Contact: Zvi Ladin, Ph.d.
• Correspondent: Zvi Ladin, Ph.d.; ECHOSENS 990 WASHINGTON STREET, STE #204 Dedham, MA 02026
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-12-10
• Decision Date: 2013-04-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03662264001048	K123806	000
03662264001031	K123806	000
03662264000072	K123806	000
03662264000058	K123806	000