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Advanced Radiation Therapy Systems, Inc.

USA · King Oof Prussia

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

1listed device types

Class I 0Class II 1Class III 0

plus 2 registration records and 4 510(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

2active device licences

Class II 2

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 States2 registration records, 4 510(k), 0 PMA, 36 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: HITACHI HIGH-TECH AMERICA, INC. RADIATION THERAPY DIVISION · BIONIX RADIATION THERAPY, LLC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K062135	ART SHIELDED BREAST APPLICATOR	2006-11-07
US	K060299	ART BRACHYTHERAPY APPLICATOR	2006-06-06
US	K972816	ADVANCED TREATMENT PLANNING SYSTEM	1998-01-23
CA	99516	ANORECTAL (AR) APPLICATOR	Class II
CA	99517	ESOPHAGEAL APPLICATOR (E-APP)	Class II

Advanced Radiation Therapy Systems, 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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