Data / Medical devices / United States / IMRIS Imaging, Inc.

IMRIS Imaging, Inc.: FDA-registered device maker in Chaska, MN, United States, 13 510(k) clearances

Name: IMRIS Imaging, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

IMRIS Imaging, Inc. is registered with the FDA (registration 3010326005) in Chaska, MN, United States. It lists 12 device types. The FDA files 13 510(k) clearances under its listings, the newest dated August 6, 2025. 15 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010326005
Address: 1230 Chaska Creek Way Suite 100, Chaska, MN, United States, 55318
Owner or operator: IMRIS Imaging, Inc. (10050332)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 4, 2015
Registered through: 2026
Brand names listed: Adult Horseshoe Pad Set, Case of 5, Application Platform 4-F NA - 2 Room Fixed, HC150 and HC300 Coils, HFD100, HFD100 Rocker Arm Accessory, Horseshoe Headrest, Horseshoe Headrest HFD100 Assembly, Horseshoe Headrest HFD200 Assembly and more

Devices it lists

Device	Product code	Class	Role	Source
Coil, Magnetic Resonance, Specialty	MOS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Device, Digital Image Storage, Radiological	LMB	1	Manufacturer	accessdata.fda.gov
Headrest, Neurosurgical	HBM	1	Manufacturer	accessdata.fda.gov
Holder, Head, Neurosurgical (Skull Clamp)	HBL	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Spectroscopic	LNI	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Ac-Powered	FQO	1	Manufacturer	accessdata.fda.gov
Table, Operating-Room, Electrical	GDC	1	Manufacturer	accessdata.fda.gov
Table, Radiologic	KXJ	2	Manufacturer	accessdata.fda.gov
Tape, Measuring, Rulers And Calipers	FTY	1	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 6, 2025	K252239	InVision 3T Recharge Operating Suite	LNH	Substantially Equivalent	Imris Imaging, Inc.	accessdata.fda.gov
February 15, 2024	K240157	InVision 1.5 Surgical Theatre	LNH	Substantially Equivalent	Deerfield Imaging, Inc.	accessdata.fda.gov
August 23, 2021	K212367	IMRIS iMRI 3T V	LNH	Substantially Equivalent	Deerfield Imaging, Inc.	accessdata.fda.gov
September 4, 2014	K141950	HFD100 ROCKER ARM ACCESSORY	HBL	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
February 10, 2014	K133692	IMRI 1.5T AND IMRI 3T S	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
March 23, 2012	K113748	IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)	HBL	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
March 11, 2011	K103493	HEAD FIATION DEVICE (HFD 100)	HBL	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
February 2, 2011	K103506	1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)	MOS	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
October 5, 2010	K101813	IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
September 2, 2009	K091166	IMRX	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
December 16, 2008	K083137	NEURO III-SV	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
May 22, 2007	K071099	NEURO II-SE, MODELS: OR-DR-OR, OR-MB	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov
August 11, 2006	K061916	NEURO II-SE, MODELS OR-MB-DR AND OR-DR	LNH	Substantially Equivalent	Imris, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 6, 2026	99596	Class II	Ongoing	ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000	The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.	accessdata.fda.gov
December 8, 2025	98132	Class II	Ongoing	Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description:	Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.	accessdata.fda.gov
September 30, 2025	97750	Class I	Ongoing	IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet, Verio	There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up wit	accessdata.fda.gov
February 17, 2022	89713	Class II	Terminated	Trumpf Mount Clamp Assembly (table adapter component), part #118704-000, a component of the IMRIS HFD100 head fixation device, models #119629-000 and #119630-000, which are used with ORT400 operating room tables.	Reports have been received that after normal or routine lateral forces are applied to the head fixation device, the split block clamp may deflect (rotationally around the axis) and not return to within acceptable distance from its prior position after the force is removed. In order to reduce deflection at the table mount location, users have tightened the ha	accessdata.fda.gov
August 25, 2021	88661	Class II	Terminated	Operating room table - Product Usage: intended for use during diagnostic examinations, radiologic procedures or surgical procedures to support and position a patient.	ORT200/300 rotational lock may fail to function such that it cannot change states between locked and unlocked, due to a mechanical hardware issue.	accessdata.fda.gov
November 26, 2019	84400	Class II	Terminated	iMRX MRI and Angiography System, part number 10094137 and 10094141, a surgical/interventional suite with integrated MRI and X-ray angiography. The IMRIS iMRX system is the integration of a Siemens Artis zee family (bipla	There is a potential hardware error for the iMRX System with a generator A100. A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible	accessdata.fda.gov
June 26, 2019	83278	Class II	Terminated	IMRIS MR/X-ray head fixation device, Model HFD200	Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying	accessdata.fda.gov
November 6, 2018	81574	Class II	Terminated	IMRIS T2X table, Part Numbers: (a)108000-000, (b)108000-600, (c)109682-000, (d) 109682-600, (e) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures	Table may drift in the roll position while in use	accessdata.fda.gov
April 4, 2018	79816	Class II	Terminated	IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative MRI systems are traditional MRI systems that have been suspended on an overhead rail system. and is designated to operative inside an RF shielded ro	The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the IFOSS control panel to malfunction.	accessdata.fda.gov
February 23, 2018	79488	Class II	Terminated	IMRIS ORT100 Table, Part Numbers: (a) 110470-000 (b) 110470-600	The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table.	accessdata.fda.gov
February 23, 2018	79366	Class II	Terminated	IMRIS ORT200 Removable Operating Room Table, 50-60 Hz Version is intended for use during diagnostic examinations or surgical procedures to support and position a patient.	The rotational locking mechanisms on the ORT 200/300 tables fail to operate such that it cannot change states between locked and unlocked.	accessdata.fda.gov
February 20, 2018	79360	Class II	Terminated	IMRIS ORT100 Table, Part Number 110470-000	The rotational locking mechanisms on the ORT 100/ T2X tables can become disengaged or unlocked while in use which could potentially result in unintended movement of the table.	accessdata.fda.gov
August 14, 2017	77996	Class II	Terminated	IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw	incorrect thread on thumbscrews	accessdata.fda.gov
February 10, 2016	73421	Class II	Terminated	Intra operative MRI Systems: Neuro II-SE, Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).	Emergency helium venting lines (i.e. quench lines) may not have been properly installed.	accessdata.fda.gov
October 1, 2014	69265	Class II	Terminated	IMRIS Operating Room table (ORT200 and ORT300). Intended for use during diagnostic examinations or surgical procedures to support and position a patient.	One of the three pins that is used to hold the ORT200 table alignment block in place on the floor of the MR Suite went missing during testing at a health care facility.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.