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Philips India Limited - Image Guided Therapy Systems Business Unit

India · Bengaluru Karn?Taka

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

10listed device types

Class I 0Class II 8Class III 2

plus 36 registration records and 28 510(k), 18 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class IV 1

18 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States36 registration records, 28 510(k), 18 PMA, 2 excluded

Brazil2 confirmed, 0 excluded

Canada1 confirmed, 1 excluded

Manufacturer names merged into this page: Philips India Limited - Image Guided Therapy Systems Business Unit · Philips Image Guided Therapy Corporation · PHILIPS IMAGE GUIDED THERAPY CORPORATION

Same-named companies — This database also contains companies with near-identical names: Philips Image Guided Therapy Corporation, Philips Image Guided Therapy Devices. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

41999

52000

42001

12002

32003

32004

22005

22020

32025

12026

FDA listed device types

showing 8 of 10

Catheter, Peripheral, Atherectomy 1Image-Intensified Fluoroscopic X-Ray System, Mobile 1System, Image Processing, Radiological 1System, X-Ray, Tomography, Computed 1Interventional Fluoroscopic X-Ray System 1System, X-Ray, Angiographic 1Catheter, Intravascular Occluding, Temporary 1System, X-Ray, Fluoroscopic, Image-Intensified 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253714	IntraSight Plus	2026-02-24
US	K253399	Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS Catheter	2025-10-28
US	K251358	Bridge Plus Occlusion Balloon (590-002)	2025-06-24
BR	10216719033	Dispositivo de travamento de cabos-eletrodos - LLD	Class II
BR	10256400063	CATETER DE SUPORTE QUICK CROSS	Class II
CA	104083	STELLAREX 0.035 INCH OTW DRUG-COATED ANGIOPLASTY BALLOON	Class IV

Philips India Limited - Image Guided Therapy Systems Business Unit

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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