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Innovative Magnetic Resonance Imaging Systems, Inc.

USA · Rockville

✓ 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

10listed device types

Class I 0Class II 10Class III 0

plus 84 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

8 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

10 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 States84 registration records, 11 510(k), 0 PMA, 6 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. · Philips India Limited - Magnetic Resonance Business Unit · SIEMENS SHENZHEN MAGNETIC RESONANCE LTD

Same-named companies — This database also contains companies with near-identical names: Magnetic Resonance Equipment Corp., Magnetic Resonance Plus, Inc., Philips India Limited - Magnetic Resonance Business Unit, Siemens Shenzhen Magnetic Resonance , Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

31993

11997

11999

12000

12001

12005

22025

12026

FDA listed device types

showing 8 of 10

Coil, Magnetic Resonance, Specialty 1Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance 1System, Planning, Radiation Therapy Treatment 1System, Tomography, Computed, Emission 1System, Nuclear Magnetic Resonance Imaging 1Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use) 1Set, I.V. Fluid Transfer 1System, Nuclear Magnetic Resonance Spectroscopic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260265	MAGNETOM Flow.Ace; MAGNETOM Flow.Plus	2026-02-23
US	K251822	MAGNETOM Free.Max; MAGNETOM Free.Star	2025-11-20
US	K250436	MAGNETOM Flow.Ace; MAGNETOM Flow.Plus	2025-06-16
BR	10345169011	Equipamento de Ressonância Magnética MAGNETOM Free.Star	Class II
BR	10345169016	MAGNETOM Flow.Ace	Class II
BR	10345161996	Equipamento de Ressonância Magnética MAGNETOM Spectra	Class II

Innovative Magnetic Resonance Imaging Systems, 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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