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Siemens Medical Systems USA, Inc.

USA · Malvern

✓ 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

14listed device types

Class I 2Class II 11Class III 1

plus 122 registration records and 846 510(k), 13 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

51active device licences

Class II 25Class III 25Class IV 1

109 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 States122 registration records, 846 510(k), 13 PMA, 58 excluded

Brazil15 confirmed, 50 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada51 confirmed, 12 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 MEDICAL SOLUTIONS USA, INC., SYNGO US · SIEMENS MEDICAL SOLUTIONS USA INC

FDA 510(k) clearances by year

242007

142008

142009

112010

182011

212012

302013

322014

242015

212016

302017

282018

262019

352020

252021

312022

252023

222024

152025

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

Siemens Medical Systems USA, 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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