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The SYMBIS Surgical System is a computer-controlled electromechanical arm. The arm is performed by the neurosurgeon. It is intended to be used in the spatial positioning and orientation of a biopsy instrument guide. Guidance is based on a pre-operative plan developed using the Medtronic StealthStation® along with fiducial marker or optical registration. The system is intended for use by neurosurgeons to guide a biopsy needle. It is intended for use by trained physicians for needle based biopsy.

The SYMBIS Surgical System is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument guide. The system is intended for use by trained physicians for needle based biopsy. The SYMBIS Surgical System consists of the a Surgeon Console, Surgical Cart, Manipulator, Robot Control Cabinet (RCC), Vision System, Platform Room Integration Kit and System Software. The Manipulator is a master/slave robot configured with either a left arm or a right arm is mounted to the Surgical Cart. The Surgical Cart is used to transport the Manipulator to and from the operating room, as well as serve as a stationary platform for robotic surgery. The Surgical Cart has an onboard immobilization system to prevent horizontal movement when positioned for surgery. The Instrument Guide is attached to the draped Manipulator and is used by the surgeon to guide the trajectory of a stereotactic instrument (e.g. Biopsy Needle). The Manipulator has six (6) degrees of freedom (DOF). The SYMBIS System provides tremor filtering and motion scaling while the surgeon positions the Manipulator and Instrument Guide to the target position. A Vision System mounted to the Surgical Cart provides the surgeon with a high definition, three-dimensional view of the patient, surgical site, and Manipulator. The Surgeon Console provides the surgeon with workstation console from which the surgeon controls the Manipulator. The Surgeon Console is located in the operating room. The surgeon, seated at the Surgeon Console, controls all movements of the Manipulator with a hand controller and foot pedal. The upper and middle displays on the Surgeon Console are medical grade, high definition monitors, and the middle monitor is capable of displaying 3 dimensional (3D) images The upper display provides the video output from a third-party navigation system (i.e. Medtronic Stealth station s7/i7). The middle display provides the 3D video output from the field camera, to provide situational awareness to the surgeon when moving the robot near the patient, surgical site, and OR staff. The video from the Vision System, along with the video from the third-party navigation system, is used by the surgeon to manipulate the Instrument Guide to the entry position. The Robot Control Cabinet (RCC) is an electronics rack and contains to operate the Surgical Cart, Manipulator and Surgeon Console. It is situated in the hospital's equipment room, adjacent to the surgical suite. The RCC includes the supporting electronic, power supply, and computers for the system. The platform room integration kit includes motor drivers to run the Manipulator, an OR Pendant with an E-Stop, cable interface mounting plates and system integration cables.

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The IMRIS Head Fixation Device System (HFD100) Rocker Arm Accessory is an MR compatible mechanical support system intended to use in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The HFD100 system is comprised of the table adapter, linkage system, one or two rocker arm skull clamps, and skull pins. The HFD100 system can be used with either the operating room table or the angiography room table. The table adaptor is used to mount HFD100 on the table. The linkage system is used to mount the Skull Clamp (including 3 or 4 skull pins) to the table Adapter. The Skull Clamp requires the use of three (3) or four (4) Skull Pins. IMRIS is using MAYFIELD® Disposable and Reusable Titanium Skull Pins manufactured by Integra LifeSciences Corporation and cleared by FDA K072208. The MAYFIELD® Disposable and Reusable Titanium Skull Pins are used in surgical procedures when rigid fixation is desired and Intra-Operative MR imaging is used. IMRIS 3-pin and 4-pin HFD100 attached to the OR table assembly is part of the IMRISneuro system. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. The HFD100 can be used individually or with the IMRIS Flexible Intra-operative Head Coils and third party accessories, such as retractor systems and navigation mounts. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. The IMRISneuro 1.5T/3T Systems (Neuro III-SV) are traditional MRI units that have been suspended on an overhead rail system to facilitate intra-operative, interventional and diagnostic use. The main components of the IMRISneuro systems are the MRI system, the magnet mover system, the OR Table assembly, the Intra-operative Coil and the Head Fixation Device. The IMRISneuro intraoperative imaging systems are tools for radiologists and surgeons, used to acquire images for diagnosis and surgical planning and monitoring during surgery. When images are requested by the surgeon, the magnet is brought into the operating room or Angiography room moving on a pair of overhead rails. The patient remains stationary throughout the procedure and the magnet moves into the room and over the patient for imaging. The magnet can be moved into and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. The surgeon has access to updated MR images in the surgical field, but does not have to change the surgery would typically be performed. Obtaining images intra-operatively allows surgeons to verify the absence of surgical complications before releasing the patient from the operating room.

The iMRI 1.5T A and 3T S are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that displays the internal structure and / or function of the head, body or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The iMRI 1.5T A and 3T S systems may also be used for imaging during intra-operative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner. The iMRI 1.5T A and 3T S MRI systems may also be used for imaging in a multi-room suite.

The IMRIS Intraoperative MRI systems (iMRI 1.5T A and iMRI 3T S) are a traditional MRI unit that has been suspended on an overhead rail system, and is designed to operate inside an RF shielded room to facilitate intra-operative and multi-room use. The magnet is normally situated in a diagnostic room until imaging is requested. For Diagnostic room purposes, the system retains the standard diagnostic features of an MRI system. The diagnostic room is separated from the intra-operative suite by sliding doors that are part of the facility structure. The iMRI system (1.5T A/3T S) is a tool for radiologists and surgeons, used to acquire images for diagnostic, intra-operative or interventional procedures. For OR purposes, high-resolution images can be obtained immediately prior to surgical incision, intraoperative and after wound closure. The iMRI 1.5T A is based on the IMRIS Neuro II-SE predicate cleared under 510(k) K071099 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The iMRI 3T S is based on the IMRIS Neuro III-SV cleared under 510(k) K083137 and the Siemens MAGNETOM Aera/Skyra MRI system cleared under 510(k) K101347. The major components of the iMRI systems are: the Siemens MAGNETOM MRI system with minor modifications; IMRIS Magnet Mover System, OR Table, RF coils and 3-pin head fixation device.

The iCT device with sliding gantry is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral plane: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the sliding gantry).

iCT is a whole body x-ray computed tomography (CT) scanner. It combines a standard CT gantry with a ceiling mounted suspension and drive mechanism to move the gantry horizontally during image acquisition. The standard CT gantry features a continuously rotating tub-detector system and functions according to the fan beam principle. The ceiling mounted suspension and drive mechanism allows iCT to be moved along rails for storage or to share the iCT between multiple rooms. The ceiling mounted system also provides precise horizontal movement that is integrated with the CT scan control. During image acquisition, the iCT drive mechanism translates the CT gantry while the patient table remains stationary. Moving the gantry allows the patient to remain stationary instead of translating the patient relative to the gantry as is required with fixed gantry systems. iCT may be used with commercially available patient tables, including surgical tables, that meet the appropriate size and x-ray transmission characteristic requirements. iCT leverages the previously cleared SOMATOM Definition, Model AS/AS+ (K081022) gantry, power supply and operator console components, including the syngo software platform and compatible syngo applications. iCT produces CT images in DICOM format. The syngo platform is able to run optional postprocessing applications.

VISIUS Wireless Coils 1.5T and 3T are intended for use with IMRIS (Siemens MAGNETOM) 1.5T and 3T MRI Systems as an imaging device for clinical procedures. VISIUS Wireless Coils produce images of the head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

The IMRIS VISIUS Wireless Coil 1.5T is a receive-only three channel flexible phased array coil. The 1.5T upper coil has two elements and the lower coil has one element. The 1.5T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 1.5T MRI system. The IMRIS VISIUS Wireless Coils, 3T is a receive-only three channel flexible phased array coil. The 3T upper coil is has two elements and the lower coil has one element. The 3T VISIUS Wireless Coils is a pair of receive-only phased array coils designed for use with the IMRIS/Siemens MAGNETOM 3T MRI system. The IMRIS 1.5T/3T VISIUS Wireless Coils balance surgical requirements with the MRI requirements to provide MR imaging in intra-operative and interventional procedures. The coils are used to acquire MR images of the head and upper C-spine during intra-operative finterventional procedures. The IMRIS 1.5T/3T Disposable Coils can also be used as standard diagnostic head coils for diagnostic examinations.

The IMRIS Oncology package uses the IMRISneuro family of Intra-operative MRI systems/Siemens MAGNETOM MR systems indicated for use as a diagnostic imaging device that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and / or spectra, and that display the internal structure and / or function of the entire body, including, but not limited to head, neck, and pelvis regions. Depending on the region of interest, contrast agents may be used. These images and / or spectra when interpreted by a trained physician yield information that may assist in diagnosis. The IMRIS Oncology Package provides an additional patient tabletop for IMRIS MR systems /Siemens MAGNETOM that allows patients to be imaged on a flat surface. The flat patient surface enables IMRIS MR system/Siemens MAGNETOM to acquire images in patient positions similar to other modalities that also utilize a flat patient surface such as X-ray, CT, PET and radiation therapy. The IMRIS MR systems/Siemens MAGNETOM MR Systems with IMRIS Oncology Package may also be used with MR safe/MR conditional patient positioning and immobilization accessories to assist in obtaining consistent patient positions throughout multiple imaging sessions.

The IMRIS Oncology Package provides an additional patient tabletop (MR SIMS table top) that can be used with IMRIS Neuro 1.5T / Siemens MAGNETOM 1.5T MRI scanners for radiation therapy planning. The MR SIMS table top allows patients to be imaged on a flat surface that matches the imaging patient position. The oncology package includes Head and Neck coil (HNC150) and Pelvic coil (PCC 150). Used in the IMRISneuro 1.5Tsystem/Siemens MAGNETOM 1.5 Tesla, it is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal, and oblique images of the internal structures of the head, neck and pelvic regions. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The IMRIS HNC150 and PCC150 coils can also be used as standard diagnostic head coils and pelvic coil respectively for diagnostic examinations. The Oncology package may be used with MR-conditional/ MR safe patient immobilization accessories to assist in consistent positions throughout multiple imaging sessions.

The IMRIS MR/X-ray Head Fixation Device System is an MR safe mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The MR/X-ray HFD is indicated for use during utilization of imaging modalities such as intraoperative MRI, CT imaging, and C-Arm X-ray angiography.

The IMRIS MR/X-ray Head Fixation Device System (HFD) is an MR safe mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is recruined for cranial stabilization. The IMRIS MR/X-ray HFD has been designed for use with intra-perative MR imaging, Xray Fluoroscopy and CT imaging modality. The IMRIS MR/X-ray HFD and its accessories are designed to immobilize the head during surgical procedures and support patient in the prone, supine or lateral positions. The IMRIS MR/A Province ട് പ്രേം കേ ray HFD system can be used with either the operating room table or the angigraphy room table. The table adaptor is used to mount IMRIS MR/X-ray HFD on the table. The linkage system is used to mont the Skull Clamp to the table Adapter. The skull clamp (including 3 skull pins) is used to hold head and neck in a particular position during surgical procedures.

The IMRIS Head Fixation Device System is an MR compatible mechanical support system which is used in head, neck and spine surgery when rigid fixation is required for cranial stabilization.

The IMRIS Head Fixation Device System (HFD100) is an MR compatible mechanical support system intended to be used in head, neck and spine surgery when rigid fixation is required for cranial stabilization. The HFD100 and its accessories are designed to immobilize the head during surgical procedures and support the patient in the prone, supine or lateral positions. The HFD100 system can be use with either the operating room table or the angiography room table. The IMRIS HFD100 consists of the Table Adapter, Linkage System. Skull Clamp and Skull Pins. The linkage system is used to mount the Skull Clamp (including 3 skull pins) to the table Adaptor is used to mount HFD100 on the table. The 3-point rigid cranial fixation device, skull clamp, provides multifunctional options for cranial stabilization and provides maximum immobilization of the patient's skull during the procedure. The HFD100 provides rigid skeletal fixation within the optimal imaging envelope during intraoperative procedure with minimal artifacts in the acquired images.

IMRIS Flex coils HC150 (1.5T Head coil) and HC300 (3T Head coil) are used in conjunction with respective MR Systems IMRIS 1.5T MAGNETOM and IMRIS 3T MAGNETOM as an imaging device for clinical procedures. IMRIS Flex coils produce images of the human head and upper C-spine internal structures. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis and therapy options.

The IMRIS 1.5T Head Coil (HC150) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC150 is a pair of receive-only phased array coils designed for use with the IMRIS 1.5T system. The IMRIS 1.5T (Neuro II-SE) uses the Siemens MAGNETOM 1.5T MRI system (MAGNETOM Espree). The IMRIS 3T Head Coil (HC300) is a receive-only eight channel phased array coil. The coil is divided into a bottom and a top array of 4 channels each. The HC300 is a pair of receive-only phased array coils designed for use with the IMRIS 3T system. The IMRIS 3T (Neuro III-SV) uses the Siemens MAGNETOM 3T MRI system (MAGNETOM Verio). The IMRIS HC150/HC300 head coils balance surgical requirements with the MRI reguirements to provide MR imaging in intra-operative and interventional procedures. Coils are used to acquire MR images of the head and upper C-spine during intra-operative /interventional procedures. The IMRIS HC150/HC300 head coils can also be used as standard diagnostic head coils for diagnostic examinations.