FUJIFILM SonoSite X-Porte 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 Fujifilm Sonosite X-porte Ultrasound System.

Pre-market Notification Details

• Device ID: K152209
• 510k Number: K152209
• Device Name: FUJIFILM SonoSite X-Porte Ultrasound System
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: FUJIFILM SONOSITE,INC. 21919 30th Dr SE Bothell, WA 98021
• 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: 2015-08-07
• Decision Date: 2015-08-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841517109424	K152209	000
00841517100964	K152209	000
00841517100971	K152209	000
00841517100988	K152209	000
00841517100995	K152209	000
00841517101008	K152209	000
00841517101015	K152209	000
00841517101022	K152209	000
00841517101039	K152209	000
00841517101046	K152209	000
00841517101053	K152209	000
00841517101060	K152209	000
00841517101077	K152209	000
00841517101084	K152209	000
00841517101091	K152209	000
00841517100957	K152209	000
00841517100933	K152209	000
00841517100926	K152209	000
00841517109493	K152209	000
00841517109417	K152209	000
00841517109431	K152209	000
00841517109448	K152209	000
00841517109455	K152209	000
00841517109462	K152209	000
00841517109479	K152209	000
00841517109486	K152209	000
00841517109509	K152209	000
00841517109516	K152209	000
00841517109523	K152209	000
00841517109530	K152209	000
00841517100360	K152209	000
00841517100377	K152209	000
00841517101107	K152209	000
00841517101114	K152209	000
00841517102746	K152209	000
00841517102753	K152209	000
00841517102760	K152209	000
00841517102807	K152209	000
00841517102814	K152209	000
00841517102821	K152209	000
00841517103323	K152209	000
00841517103330	K152209	000
00841517103385	K152209	000
00841517103392	K152209	000
00841517103408	K152209	000
00841517103415	K152209	000
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00841517103491	K152209	000
00841517102715	K152209	000
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00841517101152	K152209	000
00841517101244	K152209	000
00841517101589	K152209	000
00841517101657	K152209	000
00841517101886	K152209	000
00841517101909	K152209	000
00841517101916	K152209	000
00841517102364	K152209	000
00841517102371	K152209	000
00841517102630	K152209	000
00841517102685	K152209	000
00841517105600	K152209	000