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FUJIFILM Sonosite, Inc.

USA · Bothell

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

8listed device types

Class I 1Class II 7Class III 0

plus 36 registration records and 25 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

10 including historic records

TWTaiwanTFDA

10valid device licences

Class II 10

SGSingaporeHSA SMDR

18device registrations

CLASS B 16CLASS C 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

HKHong KongMDACS

6valid listings

Class II 6

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 7

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States36 registration records, 25 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: FUJIFILM SONOSITE,INC. · FUJIFILM SONOSITE, INC.

FDA 510(k) clearances by year

32013

12014

22015

72016

12017

12018

22019

22020

12021

12023

32025

12026

FDA listed device types

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Plethysmograph, Impedance 1Biopsy Needle Guide Kit 1System, Digital Image Communications, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260595	Sonosite iLOOK Ultrasound System	2026-03-10
US	K253448	Sonosite MT Ultrasound System	2025-11-03
US	K251106	Sonosite LX and Sonosite PX Ultrasound Systems	2025-08-29
CA	74360	BIOZ DX ICG SYSTEM WITH PHILIPS 12-LEAD ECG	Class II
CA	80079	SONOREMOTE CONTROL	Class II