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Philips Healthcare Informatics, Inc.

USA · Pleasanton

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 3 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

4listed device types

Class I 1Class II 3Class III 0

plus 15 registration records and 2 510(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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 1CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States15 registration records, 2 510(k), 0 PMA, 10 excluded

Brazil0 confirmed, 1 excluded

Canada1 confirmed, 2 excluded

Manufacturer names merged into this page: Philips India Limited - Radiology Informatics, Clinical Informatics, Patient Care Informatics Business Units · Philips Clinical Informatics · PHILIPS HEALTHCARE INFORMATICS, INC.

FDA 510(k) clearances by year

12011 · K111804

12018 · K182926

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Computer, Diagnostic, Programmable 1System, Image Processing, Radiological 1System, Digital Image Communications, Radiological 1

Market	Identifier	Name	Class / date
US	K182926	IntelliSpace Radiology	2018-12-06
US	K111804	INTELLISPACE PACS 4.X	2011-07-28
CA	62673	PACS	Class II

Philips Healthcare Informatics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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