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HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

USA · Santa Clara

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

17listed device types

Class I 5Class II 12Class III 0

plus 37 registration records and 3 510(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

0active device licences

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 States37 registration records, 3 510(k), 0 PMA, 16 excluded

Brazil1 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: HITACHI HIGH-TECH CORP., KASHIWANOHA · HITACHI HIGH-TECH CORP., NAKA DIVISION · Hitachi High-Tech Corp., Omuta Center · HITACHI HIGH-TECH CORP., Musashimurayama Center · HITACHI HIGH- TECHNOLOGIES CORPORATION NAKA DIVISION

FDA 510(k) clearances by year

12022 · K220883

12024 · K232032

12026 · K260174

FDA listed device types

showing 8 of 17

Hemoglobin A1c Test System 1Automated Occult Blood Analyzer 1Dna Genetic Analyzer 1Hexokinase, Glucose 1System, Test, Radioallergosorbent (Rast) Immunological 1Enzyme Immunoassay, Methadone 1Electrode, Ion-Specific, Chloride 1Accelerator, Linear, Medical 1

Market	Identifier	Name	Class / date
US	K260174	PROBEAT-CR	2026-06-11
US	K232032	PROBEAT-FR	2024-01-12
US	K220883	Small Field Applicator	2022-12-15
BR	10358940021	ANALISADOR GENÉTICO 3500 DX	Class II

HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION

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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