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FUJIFILM Healthcare Americas Corporation

USA · Lexington

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Hong Kong, Israel — 7 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

16listed device types

Class I 1Class II 15Class III 0

plus 18 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

17active device licences

Class II 17

63 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 1IIa 2

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

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 States18 registration records, 13 510(k), 0 PMA, 37 excluded

Brazil1 confirmed, 10 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada17 confirmed, 5 excluded

Manufacturer names merged into this page: FUJIFILM Healthcare Americas Corporation · FUJIFILM HEALTHCARE AMERICAS CORPORATION

FDA 510(k) clearances by year

52023

52024 · K233321

22025 · K251204

12026 · K261713

FDA listed device types

showing 8 of 16

System, Image Processing, Radiological 1Micro Total Analysis Instrument System 1Automated Radiological Image Processing Software 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1Des-Gamma-Carboxy-Prothrombin (Dcp), Risk Assessment, Hepatocellular Carcinoma 1Enteroscope And Accessories 1Test, Alpha Fetoprotein L3 Subfraction (Afp-L3%), For Hepatocellular Carcinoma Risk Assessment 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261713	Synapse PACS (7.6.0)	2026-06-18
US	K251204	FUJIFILM Stiffening Wire Device (SW-2000)	2025-09-26
US	K243647	Synapse PACS (7.5)	2025-06-30
BR	80022060028	SYNAPSE (PACS)	Class II
CA	34758	CHOLESTEROL C2	Class II
CA	35046	TRIGLYCERIDES 20R/30R	Class II
CA	39223	L-TYPE LIPASE AND LIPASE CALIBRATOR	Class II

FUJIFILM Healthcare Americas Corporation

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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