Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010326005

FEI Number

3010326005

Entity Name

IMRIS Imaging, Inc.

City/State/Country

Chaska, MN, US

Establishment Address

1230 Chaska Creek Way Suite 100, Chaska, MN 55318, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IMRIS Imaging, Inc. (Owner Number: 10050332)

Owner / Operator Contact Address

1230 Chaska Creek Way, Suite 100, Chaska, MN 55318, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

iCT IMRISeye Neuro II-SE MR/X-ray HFD , HFD 200/HFD210 HC150 and HC300 Coils ORT200, ORT300 ORT 400 (TruSystem 7500 MR) Table and Accessories ORT 400 (TruSystem 7500 MR) Table and Accessories iMRX System InVision 3T Recharge Operating Suite HFD100 Rocker Arm Accessory InVision 3T Operating Suite IMRIS iMRI 3T V Neuro III-SV iMRI System Neuro II-SE iMRI System inSitu Coils iMRI 1.5T A and iMRI 3T S OR Tables model ORT100, ORT200, ORT300, T2X VISIUSmatrix- 2.3, 2.4, 3 ,4 IMRISmatrix 5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2015-11-04
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2015-11-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-11-04
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2015-11-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-11-04
KXJ	Table, Radiologic	Radiology	Class 2	892.1980	2015-11-04
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2017-11-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-11-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2025-08-21
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2025-08-21
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2025-08-21
HBL	Holder, Head, Neurosurgical (Skull Clamp)	Neurology	Class 2	882.4460	2015-11-04
LNI	System, Nuclear Magnetic Resonance Spectroscopic	Radiology	Class 2	892.1000	2021-08-30
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2021-08-30
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-08-30
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-11-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-11-04
MOS	Coil, Magnetic Resonance, Specialty	Radiology	Class 2	892.1000	2015-11-04
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2015-11-04
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2015-11-04
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2015-11-04

Official Correspondent

Sanjay Shah

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IMRIS Imaging, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010326005. Last updated year: 2026. Please use registration number 3010326005 when referencing this establishment in official correspondence.