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ELEKTA SOLUTIONS AB

Sweden · Stockholm

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

24listed device types

Class I 3Class II 21Class III 0

plus 100 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 1Class II 3

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

22 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

11device registrations

CLASS B 1CLASS C 10

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

13active ARTG entries

Class I 3IIa 3IIb 7

HKHong KongMDACS

3valid listings

Class III 3

ILIsraelAMAR

9registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States100 registration records, 15 510(k), 0 PMA, 15 excluded

Brazil4 confirmed, 2 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: ELEKTA SOLUTIONS AB

FDA 510(k) clearances by year

12020

32021

22022

32023

12024

22025

32026

FDA listed device types

showing 8 of 24

System, Planning, Radiation Therapy Treatment 1Radiological Image Processing Software For Ablation Therapy Planning And Evaluation 1Accelerator, Linear, Medical 1System, X-Ray, Tomography, Computed 1Neurological Stereotaxic Instrument 1Device, Patient Transfer, Powered 1System, Image Processing, Radiological 1Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261932	Leksell® Vantage Stereotactic System	2026-08-05
US	K252002	Monaco RTP System (6.3)	2026-02-19
US	K252188	EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)	2026-01-15
BR	80569320037	Leksell Vantage Stereotactic System	Class I
BR	80569320034	PROKNOW	Class II
BR	80569320038	Kaiku Health	Class II