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ZIOSOFT, INC.

Japan · Redwood City

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Australia — 4 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

3listed device types

Class I 0Class II 3Class III 0

plus 3 registration records and 6 510(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

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIb 1

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 States3 registration records, 6 510(k), 0 PMA

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: ZIOSOFT, INC.

FDA 510(k) clearances by year

12007 · K070205

12008 · K083084

22009 · K091262

12018 · K181892

12020 · K200315

FDA listed device types

System, Nuclear Magnetic Resonance Imaging 1System, Image Processing, Radiological 1System, X-Ray, Tomography, Computed 1

Market	Identifier	Name	Class / date
US	K200315	Ziostation2	2020-05-05
US	K181892	Ziostation2	2018-10-09
US	K091262	MR CARDIAC FUNCTION ANALYSIS	2009-06-29
CA	80351	ZIOSTATION WORKSTATION SOFTWARE	Class II

ZIOSOFT, 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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