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IMRIS Imaging, Inc.

USA · Chaska

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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

13listed device types

Class I 6Class II 7Class III 0

plus 22 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

5active device licences

Class II 3Class III 2

12 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

Class I 5IIa 2IIb 1

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 States22 registration records, 1 510(k), 0 PMA, 1 excluded

Canada5 confirmed, 1 excluded

Manufacturer names merged into this page: IMRIS Imaging, Inc. · IMRIS IMAGING, INC.

FDA 510(k) clearances by year

12025 · K252239

FDA listed device types

showing 8 of 13

Coil, Magnetic Resonance, Specialty 1Table, Radiologic 1System, Nuclear Magnetic Resonance Imaging 1Holder, Head, Neurosurgical (Skull Clamp) 1System, X-Ray, Tomography, Computed 1System, Nuclear Magnetic Resonance Spectroscopic 1System, X-Ray, Angiographic 1System, Digital Image Communications, Radiological 1

Market	Identifier	Name	Class / date
US	K252239	InVision 3T Recharge Operating Suite	2025-08-06
CA	86522	IMRIS NEURO NAVIGATION	Class III
CA	86524	MR SIMULATION SYSTEM	Class II
CA	89792	IMRIS ONCOLOGY PACKAGE	Class II

IMRIS Imaging, 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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