IMRIS Imaging, Inc.
Chaska, MN, US
IMRIS Imaging, Inc. appears in FDA device records in Chaska, MN. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 29 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to IMRIS Imaging, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Deerfield Imaging, Inc.510(k), enforcement report, recall
- IMPRIS Imaging Incenforcement report, recall
- IMRIS Increcall
510(k) clearance history
FDA records hold 3 510(k) clearances for IMRIS Imaging, Inc. between 2021 and 2025. The busiest year on record is 2021, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010326005 | 3010326005 | IMRIS Imaging, Inc. | 1230 Chaska Creek Way Suite 100, Chaska, MN 55318 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MOSCoil, Magnetic Resonance, Specialty
- LMBDevice, Digital Image Storage, Radiological
- HBMHeadrest, Neurosurgical
- HBLHolder, Head, Neurosurgical (Skull Clamp)
- LMDSystem, Digital Image Communications, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- LNISystem, Nuclear Magnetic Resonance Spectroscopic
- IZISystem, X-Ray, Angiographic
- JAKSystem, X-Ray, Tomography, Computed
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- KXJTable, Radiologic
- FTYTape, Measuring, Rulers And Calipers
Recall records
Showing 25 of 29| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-3034-2026 | ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600 | 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. | Class II | Open, Classified | |
| Z-3033-2026 | 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. | Class II | Open, Classified | |
| Z-1034-2026 | 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: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component. | 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. | Class II | Open, Classified | |
| Z-0164-2026 | IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida | 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 within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-0163-2026 | IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA | 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 within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-0162-2026 | IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra | 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 within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-0161-2026 | 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 within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room. | Class I | Open, Classified | |
| Z-0934-2022 | 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 hand knob screw to a degree that it is then difficult to untighten it later in the clinical workflow. Rotational movement at the table attachment point could result in HFD movement going unnoticed, which could result in a situation where surgical or medical intervention is necessary, a situation where navigation needs to be reestablished, or a situation resulting in extended time under anesthesia for the patient. It may also be difficult to loosen the mount clamp component after use, potentially leading to ergonomic injury or a workaround during equipment teardown. | Class II | Terminated | |
| Z-2586-2021 | 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. | Class II | Terminated | |
| Z-2585-2021 | 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. | Class II | Terminated | |
| Z-2584-2021 | 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. | Class II | Terminated | |
| Z-0762-2020 | 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 (biplane or floor or ceiling mounted single plane) and the IMRIS Neuro 3T System. The System is a solution providing MRI scanning capabilities in the angiography room while retaining all functionality of Siemens Artis zee system. The System includes a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside RF room to facilitate intra-operative, interventional, and multi-room imaging. It also allows intra-operative or interventional imaging capabilities, while retaining all diagnostic functionality of a standard MRI system in the diagnostic room. The iMRX system allows for the sequential use of either MR imaging or X-ray fluoroscopic imaging of the head or chest for a single patient while positioned on a common fixed table either prior to, during or post clinical procedure. When these images are interpreted by a trained physician, they may assist in diagnosis during either neurovascular or cardiovascular interventionsa procedures. The iMRX system is designed such that the imaging sub-systems cannot operate simultaneously and only in accordance with their respective cleared intended use. | 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 | Class II | Terminated | |
| Z-0163-2020 | 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 the issue and not being able to continue with the procedure. | Class II | Terminated | |
| Z-0648-2019 | IMRIS ORT 300, Removable Operating Room Table, Part Numbers: (a) 114093-000, (b) 114093-006 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient. | Table may drift in the roll position while in use | Class II | Terminated | |
| Z-0647-2019 | IMRIS ORT 200, Removable Operating Room Table, Part Numbers: (a) 113821-000, (b) 113821-600, (c) 114148-000, (d) 114148-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient. | Table may drift in the roll position while in use | Class II | Terminated | |
| Z-0646-2019 | IMRIS ORT 100 table, Part Numbers: (a) 110470-000, (b) 110470-600 - Product Usage: The ORT200 and ORT300 are intended for use during diagnostic examinations, radiologic procedures, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient. | Table may drift in the roll position while in use | Class II | Terminated | |
| Z-0645-2019 | 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, or surgical procedures to support and position a patient. The tables are indicated for imagining from head to sacrum with MR/CT imaging modalities. The ORT100 table is intended for use during diagnostic examination or surgical procedures to support and position the patient. | Table may drift in the roll position while in use | Class II | Terminated | |
| Z-1645-2018 | 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 room to facilitate intraoperative and multi room use. | 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. | Class II | Terminated | |
| Z-1266-2018 | IMRIS ORT300, Removable Operating Room Table, Part Numbers: (a) 114093-000 (b) 114093-600 | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | Class II | Terminated | |
| Z-1265-2018 | IMRIS T2X Table, Part Numbers: (a) 108000-000 (b) 108000-600 (c) 109682-000 (d) 109682-600 | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | Class II | Terminated | |
| Z-1264-2018 | IMRIS ORT200, Removable Operating Room Table, Part Numbers: (a) 113821-000 (b) 113821-600 (c) 114148-000 (d) 114148-600 | The Operating Room Table may drift while in use, which could potentially result in unintended movement of the table. | Class II | Terminated | |
| Z-1263-2018 | 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. | Class II | Terminated | |
| Z-1218-2018 | IMRIS ORT300 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. | Class II | Terminated | |
| Z-1217-2018 | 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. | Class II | Terminated | |
| Z-0976-2018 | IMRIS T2X Table, Part Number 109682-600 | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain