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Spectrum Dynamics , Ltd.

Israel · Kfar Saba

✓ 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

4listed device types

Class I 0Class II 4Class III 0

plus 14 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

5 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 States14 registration records, 12 510(k), 0 PMA, 41 excluded

Brazil3 confirmed, 5 excluded

Canada0 confirmed, 7 excluded

Manufacturer names merged into this page: Spectrum Dynamics Medical Ltd. · Spectrum Dynamics Medical Inc. · SPECTRUM DYNAMICS MEDICAL LTD. · SPECTRUM DYNAMICS (ISRAEL) LTD · SPECTRUM DYNAMICS MEDICAL LTD

FDA 510(k) clearances by year

12006

12007

12011

22016

22018

12019

12021

12023

12025

12026

FDA listed device types

System, Tomography, Computed, Emission 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, X-Ray, Tomography, Computed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K254001	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	2026-01-13
US	K253532	TruSPECT Processing Station	2025-12-30
US	K230600	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	2023-04-28
BR	80012590219	Sistema de Imagens Cardíacas D-SPECT	Class II
BR	80012590228	CORRIDOR 4DM	Class II
BR	80012590229	CARDIAC SUIT	Class II

Spectrum Dynamics , Ltd.

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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