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Philips Ultrasound, Inc.

USA · Bothell

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

9listed device types

Class I 1Class II 8Class III 0

plus 328 registration records and 77 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class II 16

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

SASaudi ArabiaSFDA

20registered imported devices

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

CACanadaMDALL

14active device licences

Class II 2Class III 12

55 including historic records

TWTaiwanTFDA

20valid device licences

Class II 20

SGSingaporeHSA SMDR

25device registrations

CLASS B 11CLASS C 14

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

20active ARTG entries

Class I 3IIa 17

HKHong KongMDACS

11valid listings

Class II 11

ILIsraelAMAR

14registrations

RURussiaRoszdravnadzor

16active registrations

Class 2a 16

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 States328 registration records, 77 510(k), 0 PMA, 48 excluded

Brazil16 confirmed, 7 excluded

Saudi Arabia20 confirmed, 3 excluded

Canada14 confirmed, 3 excluded

Manufacturer names merged into this page: Philips Ultrasound (Shanghai) Co., Ltd · Philips Ultrasound LLC · Philips India Limited - Ultrasound Business Unit · Philips Global Business Services LLP - Ultrasound Business Unit · PHILIPS ULTRASOUND LLC · PHILIPS ULTRASOUND

FDA 510(k) clearances by year

12005

22006

12007

22008

12009

12010

32011

22012

32013

32014

12016

22017

42018

62020

22021

12022

52023

52024

122025

72026

FDA listed device types

showing 8 of 9

Automated Radiological Image Processing Software 1System, Image Processing, Radiological 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1System, X-Ray, Tomography, Computed 1Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer 1Catheter, Ultrasound, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K262311	Alturion Series Diagnostic Ultrasound System	2026-08-04
US	K261211	Philips EPIQ Series Diagnostic Ultrasound System; Philips Affiniti Series Diagnostic Ultrasound System	2026-07-27
US	K260667	Alturion Series Diagnostic Ultrasound System	2026-06-29
BR	10216710187	CX50 SISTEMA DE ULTRA-SOM E TRANSDUTORES	Class II
BR	10216710228	Equipamento de Ultrassom para Diagnóstico Clear Vue	Class II
BR	10216719034	Sistema de Ultrassom Flash 5100 POC	Class II
SA	ME0000003255SFDAA00030	PercuNav Ultrasound Tracker	—
SA	ME0000003255SFDAA00032	PercuNav Tool Connection Unit	—
CA	541	APOGEE 800+ DIAGNOSTIC SYSTEM	Class II
CA	28529	EXTREME VIEWER	Class II
CA	37084	HDI 4000 ULTRASOUND SYSTEM	Class III