SonoSite Edge II Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM SONOSITE,INC.

The following data is part of a premarket notification filed by Fujifilm Sonosite,inc. with the FDA for Sonosite Edge Ii Ultrasound System.

Pre-market Notification Details

• Device ID: K153626
• 510k Number: K153626
• Device Name: SonoSite Edge II Ultrasound System
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell, WA 98021 -3904
• Contact: Patricia Liau
• Correspondent: Mark Job; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• 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: Yes
• Combination Product: No
• Date Received: 2015-12-18
• Decision Date: 2016-01-20
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841517110277	K153626	000
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