Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3032367

FEI Number

3002087856

Entity Name

FUJIFILM SONOSITE,INC.

City/State/Country

BOTHELL, WA, US

Establishment Address

21919 30th Dr SE, BOTHELL, WA 98021, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FUJIFILM CORPORATION (Owner Number: 8031568)

Owner / Operator Contact Address

26-30, Nishiazabu 2-chome, MINATO-KU, JP-13 106-8620, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251106

PMA Number

N/A

All Registered Proprietary Names

Sonosite PX Ultrasound System SonoSite SII Ultrasound System Edge Ultrasound System S-ICU Ultrasound System SonoSite Maxx Series Ultrasound System M-Turbo Ultrasound System S-Women's Health Ultrasound System S-Nerve Ultrasound System S-Cath Ultrasound System S Series Ultrasound System S-MSK Ultrasound System M-MSK Ultrasound System M-OB/Gyn Ultrasound System S-FAST Ultrasound System MicroMaxx Ultrasound System MicroMaxx High-Resolution Ultrasound System SonoSite MicroMaxx Ultrasound System iViz Ultrasound System SonoSite X-Porte Ultrasound System S-Women's Health Ultrasound System M-OB/Gyn Ultrasound System S-FAST Ultrasound System M-Turbo Ultrasound System S-Nerve Ultrasound System M-MSK Ultrasound System S-Cath Ultrasound System S-ICU Ultrasound System S-MSK Ultrasound System SonoSite Maxx Series Ultrasound System S Series Ultrasound System MicroMaxx Ultrasound System Cable, Leadwires, ECG External ECG Connector Cable and Adapter C5-1 MHz Transducer C10-3 MHz Transducer IC10-3 MHz Transducer L12-3 MHz Transducer L15-4 MHz Transducer Sonosite PX Ultrasound System P5-1 MHz Transducer T8-3 MHz Transducer Sonosite ECG Module Leadwires Sonosite LX Ultrasound System Sonosite ECG Module L19-5 MHz Transducer Sonosite ZX Ultrasound System Sonosite ST Ultrasound System S-Nerve Ultrasound System S-Women's Health Ultrasound System M-OB/Gyn Ultrasound System S Series Ultrasound System M-Turbo Ultrasound System S-ICU Ultrasound System NanoMaxx Ultrasound System S-Cath Ultrasound System S-MSK Ultrasound System M-MSK Ultrasound System S-FAST Ultrasound System Maxx Series Ultrasound System Sonosite LX Ultrasound System UHF46-20 Transducer SonoSite Edge II Ultrasound System SonoSite SII Ultrasound System X-Porte Ultrasound System X-Porte Ultrasound Kiosk SonoSite Vevo MD Imaging System Vevo MD Imaging System FUJIFILM SonoSite Vevo MD Imaging System SonoSite SII Ultrasound System SonoSite iViz Ultrasound System iViz Ultrasound System NanoMaxx Ultrasound System SonoSite NanoMaxx Series Ultrasound System X-Porte Ultrasound System X-Porte Ultrasound Kiosk X-Porte Ultrasound Kiosk X-Porte Ultrasound System Edge Ultrasound System iViz Ultrasound System Vevo MD Imaging System FUJIFILM SonoSite Vevo MD Imaging System SonoSite Vevo MD Imaging System Sonosite LX Ultrasound System Sonosite PX Ultrasound System Sonosite ST Ultrasound System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2020-05-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2020-05-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2020-05-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2020-05-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-02-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-02-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-02-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-10-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-10-23
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-10-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-10-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-06
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2018-04-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2018-04-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2018-04-18
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2017-06-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2017-06-14
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2017-06-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-10-25
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-10-25
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-10-25
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-12-27
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-12-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2021-12-27
OIJ	Biopsy Needle Guide Kit	Radiology	Class 2	892.1560	2021-12-27
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-06
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-07-15
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-07-15
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-07-15
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-28
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-08
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-08
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-08
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-05-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-05-05
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-05-05
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-04-07
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-04-07
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-04-07
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-10-28
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-10-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-10-28
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-11-13
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-11-13
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2013-11-06
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2013-11-06
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2015-08-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2015-08-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2015-08-20
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-09-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-09-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2014-01-23
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2014-01-23
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2014-01-23
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2016-05-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2016-05-16
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2016-05-16
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2019-03-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2019-03-18
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2019-03-18
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2025-11-20
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2025-11-20
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-11-20
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2025-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

FUJIFILM CORPORATION

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3020707080	FUJIFILM medwork GmbH	Hochstadt/Aisch Bavaria, DE
3008787461	FUJIFILM Imaging System (Suzhou) Co., Ltd.	Suzhou Jiangsu, CN
2155	FUJIFILM Healthcare Manufacturing Corporation Minamiashigara Takematsu Office	MINAMIASHIGARA-SHI Kanagawa, JP
3005625991	FUJIFILM Healthcare Americas Corporation	Edison, NJ, US
3034364687	FUJIFILM Corporation Material Manufacturing Headquarters	Fujinomiya Shizuoka, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0189-2022	FujiFilm Healthcare Americas Corporation	2	Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3032367. Last updated year: 2026. Please use registration number 3032367 when referencing this establishment in official correspondence.