IMRIS Imaging, Inc.

Matched from indexed company URL: IMRIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3010326005	3010326005	IMRIS Imaging, Inc.	1	Y	2026-01-01	1230 Chaska Creek Way Suite 100 Chaska MN US 55318

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
187920	1774143053	K252239	InVision™ 3T Recharge Operating Suite	LNH	2025-08-06
187920	1650329980	K240157	InVision™ 1.5 Surgical Theatre	LNH	2024-02-15
187920	1506262020	K212367	IMRIS iMRI 3T V	LNH	2021-08-23
187920	1543122549	K143420	SYMBIS Surgical System	HAW	2015-10-30
187920	1767080166	K141950	HFD100 ROCKER ARM ACCESSORY	HBL	2014-09-04
187920	1228697148	K133692	IMRI 1.5T AND IMRI 3T S	LNH	2014-02-10
187920	1069149001	K130224	ICT	JAK	2013-07-18
187920	1151117555	K123091	VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T	MOS	2012-12-27
187920	1061731602	K121997	IMRIS ONCOLOGY PACKAGE	LNH	2012-08-10
187920	1172702651	K113748	IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)	HBL	2012-03-23
187920	1689850722	K103506	1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)	MOS	2011-02-02
187920	1935092122	K103493	HEAD FIATION DEVICE (HFD 100)	HBL	2011-03-11
187920	1537678672	K101813	IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO	LNH	2010-10-05
187920	1339742290	K091166	IMRX	LNH	2009-09-02
187920	2064774402	K083137	NEURO III-SV	LNH	2008-12-16
187920	1271757646	K071099	NEURO II-SE, MODELS: OR-DR-OR, OR-MB	LNH	2007-05-22
187920	1064112780	K061916	NEURO II-SE, MODELS OR-MB-DR AND OR-DR	LNH	2006-08-11
187920	1187005946	K050132	NEURO II-S	LNH	2005-02-15
187920	1104877398
187920	1335638648
187920	1608038986
187920	1669307520
187920	1921099424
187920	1962162199
187920	2016592628

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LNH	11	2025-08-06
HBL	3	2014-09-04
MOS	2	2012-12-27
HAW	1	2015-10-30
JAK	1	2013-07-18

PMN#

InVision? 3T Recharge Operating Suite

2025-08-06

Imris Imaging, Inc.

SYMBIS Surgical System

2015-10-30

IMRIS, Inc.

HFD100 ROCKER ARM ACCESSORY

2014-09-04

IMRIS, INC.

IMRI 1.5T AND IMRI 3T S

2014-02-10

IMRIS, INC.

ICT

2013-07-18

IMRIS, INC.

VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T

2012-12-27

IMRIS, INC.

IMRIS ONCOLOGY PACKAGE

2012-08-10

IMRIS, INC.

IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)

2012-03-23

IMRIS, INC.

HEAD FIATION DEVICE (HFD 100)

2011-03-11

IMRIS, INC.

1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)

2011-02-02

IMRIS, INC.

IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

2010-10-05

IMRIS, INC.

IMRX

2009-09-02

IMRIS, INC.

NEURO III-SV

2008-12-16

IMRIS, INC.

NEURO II-SE, MODELS: OR-DR-OR, OR-MB

2007-05-22

IMRIS, INC.

NEURO II-SE, MODELS OR-MB-DR AND OR-DR

2006-08-11

IMRIS, INC.

GUDID#

IMRISeye - ALIGNMENT RING ASSEMBLY, SSF

IMRIS Imaging, Inc.

2026-05-07

Horseshoe Headrest - Horseshoe Headrest HFD200 Assembly, 116343-000

IMRIS Imaging, Inc.

2016-10-01

Horseshoe Headrest - Horseshoe Headrest HFD100 Assembly, 116341-000

IMRIS Imaging, Inc.

2016-10-01

Neuro II-SE - Model 105000-00X include the following: 105000-000, OR-MB Configuration105000-001, OR-DR Config105000-002, OR-MB-DR Config105000-003, OR-MB-OR Config105000-004, OR-DR-OR Config105119-001, Multi-Room Imaging Suite MR15L Oracle OR-DR105087-000, Multi Room Imaging Suite, MR15LS OR-DR

IMRIS Imaging, Inc.

2026-03-20

iMRX System - iMRX System AR-DR MR30RS,105824-000

IMRIS Imaging, Inc.

2016-09-23

iMRX System - iMRX System AR-DR-AR, MR30R, 105826-000

IMRIS Imaging, Inc.

2016-09-23

iMRX System - iMRX System AR-DR-OR, MR30R, 105828-000

IMRIS Imaging, Inc.

2016-11-04

iMRX System - iMRX System Post Assy, 1.5T 16CH Cardiac Coil,105856-000

IMRIS Imaging, Inc.

2016-11-04

iMRX System - iMRX System ANTERIOR ASSY, 3T 16CH CARDIAC COIL, 105587-000

IMRIS Imaging, Inc.

2016-11-04

iMRX System - iMRX System POSTERIOR ASSY, 3T 16CH CARDIAC COIL, 105589-000

IMRIS Imaging, Inc.

2016-09-23

iMRX System - iMRX System Ant Assy, 1.5T 16CH Cardiac Coil, 105855-000

IMRIS Imaging, Inc.

2016-09-23

IMRISmatrix 5.0 - Applications Platform 5.0 2 Room, North America, Japan

IMRIS Imaging, Inc.

2025-09-18

IMRISmatrix 5.0 - Applications Platform 5.0 3 Room, North America, Japan

IMRIS Imaging, Inc.

2025-09-18

InVision™ 3T Recharge Operating Suite - P122181

IMRIS Imaging, Inc.

2025-09-18

ORT 400 (Trumpf TruSystem 7500 MR Neuro) table - ORT 400 table MR Neuro Accessory Adaptor- 120025-000

IMRIS Imaging, Inc.

2018-09-20

HC150 - 1.5T Head Coil Upper Assy Neuro II S - Upper Coil Assemblt 1.5T Neuro II-S, 119976-000

IMRIS Imaging, Inc.

2018-03-05

HC150 - 1.5T Head Coil Lower Neuro II-S - LOWER COIL ASSEMBLY, 1.5T Neuro II-S, 119980-000

IMRIS Imaging, Inc.

2018-03-05

ORT 400 (Trumpf TruSystem 7500 MR) table - ORT 400 (Trumpf TruSystem 7500 MR) table Assembly, 119493-000

IMRIS Imaging, Inc.

2017-11-20

ORT 400 (Trumpf TruSystem 7500 MR) table - ORT 400 (Trumpf TruSystem 7500 MR) table, Control Panel Assy 119409-000

IMRIS Imaging, Inc.

2017-11-20

ORT100 Table - T2X OR Table V.2, 110470-600

IMRIS Imaging, Inc.

2017-02-28

ORT200 Table - ORT200 50/60Hz Covered Table Assy V2, 114148-600

IMRIS Imaging, Inc.

2017-03-31

ORT300 Table - ORT300 Modular Table Main Unit Assy, 114093-600

IMRIS Imaging, Inc.

2017-02-28

HC150 - 1.5T Head Coil Lower - LOWER ASSEMBLY, 1.5T IOHv2, SAE, 118995-600

IMRIS Imaging, Inc.

2017-02-28

HC150 - 1.5T Head Coil Lower Assy - Lower Assembly, 1.5T IOHv2 (Es), 110821-600

IMRIS Imaging, Inc.

2017-02-28

HC300 -3T Head Coil Lower Assy - Lower Assy, 3T IOH V2, 110840-600

IMRIS Imaging, Inc.

2017-02-28

HC300- 3T Head Coil Upper Assy - Upper Assy, 3T IOH V2, 110833-600

IMRIS Imaging, Inc.

2017-02-28

HC150 - 1.5T Head Coil Upper Assy - Upper Assembly, 1.5T IOHv2 (Es/SAE), 110812-600

IMRIS Imaging, Inc.

2017-02-28

Head Fixation Device HFD100 - Head Fixation Device HFD100 , 113803-600

IMRIS Imaging, Inc.

2017-02-28

InSitu Coil, 1.5T - InSitu Coil, Open, 1.5T Large, Pouched,114892-001

IMRIS Imaging, Inc.

2016-11-23

ORT300 Table - ORT300 Modular Table Main Unit Assy, 114093-000

IMRIS Imaging, Inc.

2016-09-12

ORT200 Table - ORT200 50/60Hz Covered Table Assy V2, 114148-000

IMRIS Imaging, Inc.

2016-09-22

ORT100 Table - T2X OR Table V.2, 110470-000

IMRIS Imaging, Inc.

2016-09-22

VISIUSeye - VISIUSeye iMRI 1.5T A and 3TS, 117534-000

IMRIS Imaging, Inc.

2018-06-03

HFD100 Rocker Arm Accessory - Rocker Arm Accessory Kit HFD100, 117948-000

IMRIS Imaging, Inc.

2016-09-01

HC150 - 1.5T Head Coil Upper Assy - Upper Assembly, 1.5T IOHv2 (Es/SAE), 110812-000

IMRIS Imaging, Inc.

2016-09-12

HC150 - 1.5T Head Coil Lower Assy - Lower Assembly, 1.5T IOHv2 (Es), 110821-000

IMRIS Imaging, Inc.

2016-09-12

HC300- 3T Head Coil Upper Assy - Upper Assy, 3T IOH V2, 110833-000

IMRIS Imaging, Inc.

2016-09-05

HC300 -3T Head Coil Lower Assy - Lower Assy, 3T IOH V2, 110840-000

IMRIS Imaging, Inc.

2016-09-05

iCT - iCT System 115219-000

IMRIS Imaging, Inc.

2016-09-01

Neuro III-SV iMRI System - Neuro III-SV Multi-Room Imaging Suite MR30LS Enhancement OR-DR, 116189-000

IMRIS Imaging, Inc.

2016-09-22

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