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SIEMENS MEDICAL SOLUTIONS USA, INC.

USA · Hoffman Estates

✓ 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

14listed device types

Class I 2Class II 11Class III 1

plus 122 registration records and 906 510(k), 20 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

15registered devices

Class II 15

22 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

54active device licences

Class II 26Class III 27Class IV 1

112 including historic records

TWTaiwanTFDA

19valid device licences

Class II 19

SGSingaporeHSA SMDR

26device registrations

CLASS B 18CLASS C 7CLASS D 1

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

13active ARTG entries

Class III 1IIa 9IIb 3

HKHong KongMDACS

17valid listings

Class II 10Class III 4Class IV 3

ILIsraelAMAR

31registrations

RURussiaRoszdravnadzor

36active registrations

Class 2a 25Class 2b 10Class 3 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 States122 registration records, 906 510(k), 20 PMA, 54 excluded

Brazil15 confirmed, 50 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada54 confirmed, 11 excluded

Manufacturer names merged into this page: SIEMENS MEDICAL SOLUTIONS USA, INC. · Siemens Medical Solutions USA, Inc. · SIEMENS MEDICAL SOLUTIONS USA, INC. ONCOLOGY CARE SYSTEMS · SIEMENS MEDICAL SOLUTIONS USA, INC. MOLECULAR IMAGING · SIEMENS AG MEDICAL SOLUTIONS · SIEMENS MEDICAL SOLUTIONS USA INC

Same-named companies — This database also contains companies with near-identical names: Siemens Medical Solution, Inc. USA, Siemens AG Medical Solutions, Siemens Medical Solutions U.S.A.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

302007

212008

192009

152010

192011

212012

312013

352014

272015

262016

322017

322018

282019

362020

252021

332022

292023

242024

172025

92026

FDA listed device types

showing 8 of 14

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1Transducer, Ultrasonic, Diagnostic 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Tomography, Computed, Emission 1System, Imaging, Pulsed Doppler, Ultrasonic 1Full Field Digital, System, X-Ray, Mammographic 1Biopsy Needle Guide Kit 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253786	syngo.CT Coronary Cockpit	2026-06-25
US	K253678	MAMMOMAT B.brilliant (11372950)	2026-06-18
US	K260844	ACUSON Sequoia Diagnostic Ultrasound System;ACUSON Sequoia Select Diagnostic Ultrasound System;ACUSON Origin Diagnostic Ultrasound System;ACUSON Origin ICE Diagnostic Ultrasound System	2026-06-16
BR	10345162479	syngo MBF	Class II
BR	10345162490	syngo.via MI Workflows	Class II
BR	10345162501	Scenium	Class II
CA	15152	SIMVIEW NT	Class III
CA	4950	MULTISPECT 3	Class II
CA	4956	ICON WORKSTATION	Class II