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Device-Specific Indications for Use/Intended Use: This device is intended for use as part of the AirDrive system to facilitate diagnostic and image guided procedures including under fluoroscopy, X-ray, CT, MR, other imaging procedures, and other procedures involving transfer of a patient. System Indications for Use/Intended Use: The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix has made a modification to its previously cleared Symphony Patient Transport System (cleared in K160627). This modification introduces a new transfer device variant compatible with the Symphony Patient Transport System – the Iris AirShuttle is designed to be used with an AirDrive source, such as the AirDrive Trolley or AirDrive Caddie, to provide a solution for a complete patient transport system. With the Iris AirShuttle, the system is capable of being used in multimodal imaging and treatment environments, including interventional radiology procedures and workflows involving fluoroscopy, angiography, and magnetic resonance imaging. To facilitate these workflows, user configurable accessory rails have been added to the design, allowing easy transfer of essential railmounted equipment with the patient. Additionally, the Iris AirShuttle allows for patient transfer on soft and hard surfaces. Device pads have been included in the modification to maximize patient comfort while minimizing the distance between the patient and the spine coil of MR machines for optimal image quality. Alternative integrated transfer handles have also been included to allow for transfers with or without air power and without installation of the removable transfer handles. Qfix intends to market the subject device for use with the AirDrive Trolley and the AirDrive Caddie. This creates an improved efficient workflow while reducing the risk of injuries related to manually lifting patients for transport in various treatment environments, including multimodal imaging and treatment workflows involving fluoroscopy, angiography, and magnetic resonance imaging.

The Alta™ Multipurpose Device is intended to immobilize, support, position, and transfer patients undergoing radiotherapy procedures using electrons, protons, including SBRT and SRS; imaging procedures such as x-ray, computed tomography, and magnetic resonance imaging; and other procedures involving transfer of a patient. The Alta™ Multipurpose Device is designed to interface with the Symphony® Patient Transport System and other positioning devices, such as couch tops, thermoplastic masks, setup-specific treatment devices and adapters, and positioning supports and pads.

Qfix has developed a new device designed to streamline radiotherapy and imaging workflows, the Alta™ Multipurpose Device. The Alta Multipurpose Device is intended to immobilize, support, position, and transfer patients undergoing radiotherapy procedures using electrons, photons, protons, including SBRT and SRS; imaging procedures such as x-ray, computed tomography, and magnetic resonance imaging: and other procedures involving transfer of a patient. The Alta Multipurpose Device is designed to interface with the Symphony® Patient Transport System and other positioning devices, such as couch tops, thermoplastic masks, setup-specific treatment devices and adapters, and positioning supports and pads. The Alta Multipurpose Device is a versatile device, providing access for a variety of clinical setups for transport, imaging, and treatment on a single device. The proprietary fiber-reinforced composite construction of the Alta Multipurpose Device provides strong and rigid support while remaining lightweight for ease of transport and use. The Alta Multipurpose Device boad-reaching compatibility with a variety of positioning and immobilization devices, including but not limited to: - Headrests, adapters, and thermoplastics for head and neck applications, including intracranial, whole brain, and stereotactic radiosurgery (SRS), - MR Coil Holders, ● - Vacuum cushions for stereotactic body radiation therapy (SBRT), ● - . Bridges and compression devices for SBRT. - Supine positioning devices for breast and thorax applications, - Thoracic and pelvis thermoplastics for thorax and pelvis applications, ● - Upper and lower extremity positioning devices, like hand grips, arm positioners. ● and knee and foot blocks. When combined with such other devices through its variety of indexing features, the Alta Multipurpose Device enables a diverse set of clinical applications within the fields of radiotherapy and diagnostic imaging all with the same device, providing significant flexibility, agility, and efficiency for clinicians. Additionally, the Alta Multipurpose Device can optionally be configured to utilize Symphony Air Drive™ technology to facilitate patient transfers with the Symphony Patient Transport System, further enabling more efficient clinical workflows.

The Encompass™ 15 Channel Head Coil is intended to be used in conjunction with a Magnetic Resorance Scanner for the MR examination of the human brain just before, during, and at the end of brain surgery. The Encompass™ 15 Channel Head Coil can also be used as a standard diagnostic examinations and fMRI (Functional Magnetic Resonance Imaging). When used with magnetic resonance imaging systems, 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. When interpreted by a trained physician, these images provide information that can be useful in determining diagnosis.

Qfix and NORAS MRI products GmbH have jointly developed a head coil designed to enable MRI for diagnosis and to inform additional clinical actions, the Encompass™ 15 Channel Head Coil, 3T. The Encompass 15 Channel Head Coil is a diagnostic imaging device for use in 3T environments for obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments. The Encompass™ 15 Channel Head Coil has been specifically designed to interface with the Encompass™ SRS Immobilization System (cleared with K152321 December 4, 2015). The Encompass™ 15 Channel Head Coil is a ridged receive only coil featuring a 7 Channel Top Coil, an 8 Channel Bottom Coil, and an optional mirror holder. Imaging is performed with a 15-Channel "phased array" co-developed by Qfix and NORAS and manufactured by NORAS. The coils are mounted in a rigid Coil Frame and connection to the MRI is managed by the applicable MRI software. The Encompass™ 15 Channel MRI Head Coil has been designed for use with Siemens Healthineers MAGNETOM 3T systems e.g. MAGNETOM Skyra. Encompass™ 15 Channel Head Coil has been optimized for use with the Encompass™ SRS Immobilization System. The use of the Encompass™ 15 Channel Head Coil together with the Encompass™ SRS Immobilization System allows immobilization of the patient while obtaining diagnostic MR images to be used to inform procedures which use MR imaging to guide interventional procedures and other treatments.

The Encompass™ SRS Headframe provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. repositioning, and immobilization. The Encompass™ SRS Headframe allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

Qfix, has made a modification to its previously cleared Encompass™ SRS Immobilization System (cleared in K152321). In this modified variant of the Encompass™ SRS Immobilization System, the essential geometry of the head portion of the Encompass™ SRS Standalone Device is isolated to create a separate attachment which can be affixed to patient positioning devices that accept S-type thermoplastic masks, such as Qfix's Portrait™ Intracranial, Head and Neck Device (a device for use with S-type thermoplastics). Ofix intends to initially market the subject device for use with the Encompass™ SRS Fibreplast® System with optional IntegraBite™ (also cleared in K152321) and its devices which share a hole pattern and geometry with its Portrait™ Intracranial, Head and Neck Device. Examples of such devices include the kVue™ Portrait™ Intracranial. Head and Neck Insert and the Symphony® Portrait™ Transfer Device (cleared in K160627). This creates a flexible solution for a variety of imaging and radiotherapy treatment applications using stereotactic radiosurgery, such as radiation oncology and the treatment of noncancerous conditions and malformations such as trigeminal neuralgia.

Device-Specific Intended Use: The Qfix® Abdominal/Thoracic Motion Control System is intended to apply abdominal compression for managing internal body motion during respiration while maintaining maximum comfort to the patient. The Qfix® Abdominal/Thoracic Motion Control System is also intended to promote shallow breathing in radiation therapy or radiology. System Intended Use: The Qfix® Abdominal/Thoracic Motion Control System can be used as part of the Qfix® SBRT Solution and Accessories including, Ofix's kVue™, Stradivarius™, VacQFix™ and DoseMax™ inserts, overlays, and standalone devices which are intended to immobilize, position patients undergoing radiation therapy including SBRT.

Ofix has developed an improved device. the Ofix® Abdominal/Thoracic Motion Control System, to promote shallow breathing in patients undergoing radiation therapy including electron, photon, and proton treatments and general radiology and imaging applications including MR and CT image acquisition. The Ofix® Abdominal/Thoracic Motion Control System is intended to be used either independently or in conjunction with a number of existing devices and accessories in the Ofix portfolio to create a comprehensive solution for stereotactic body radiation therapy. The Ofix® Abdominal/Thoracic Motion Control System features belts and paddles of varying size, an air bladder, and a hand pump with gauge. The belts come in multiple sizes to accommodate wide range of patient girths. The rigid foam paddles are designed with geometry that conforms to the region beneath the xibhoid process, in order to provide relatively comfortable compression that does not compress the ribs themselves. The paddles also feature embedded fiducial markers, providing another means of positional localization. Compression is achieved via a bladder attached to the paddles, designed to maintain a flat profile even when fully inflated in order to achieve uniform pressure on the paddle through the course of the procedure. The bladder, which is inflated with a detachable small hand pump with gauge, features a pressure-holding valve and a quick release at the junction of the pump and the inflation tubing. This allows the Abdominal/Thoracic Motion Control System to reliably hold its pressure without the pump in place, enabling more flexibility and versatility in studies and procedures. At the time of this submission. the Ofix® Abdominal/Thoracic Motion Control System is patent pending. The Qfix® Abdominal/Thoracic Motion Control System can be used in conjunction with other devices already in the Qfix Product Portfolio to achieve further body immobilization or greater degrees of compression with the Qfix® SBRT Solution and Accessories. It combines a rigid, low attenuating support structure in the form of a couchtop insert or overlay with a series of interchangeable devices such as supportive cushions, compression devices, and other immobilization devices, including the Qfix® Abdominal/Thoracic Motion Control System, allowing clinicians to provide superior immobilization customized to the unique treatment plan of each patient.

The Qfix® Symphony Patient Transport System is indicated to aid in the support, positioning, and transfer of a patient for procedures involving imaging, including MRI; and external beam radiation therapy treatment with electrons, photons or protons; and other procedures requiring transfer of a patient. The Symphony is designed to interface with other positioning devices, such as couchtops, inserts, thermoplastic masks, and positioning pads.

Qfix, has developed the Symphony™ Patient Transport System to seamlessly move patients among multiple imaging modalities such as MR and CT to treatment modalities, such as those utilizing photon or proton and other procedures requiring the transfer of a patient. The Symphony™ Patient Transport System is designed to utilize a low-friction air bearing to transfer patients from one surface to another, eliminating the need to manually lift the patient. Additionally, the design enables clinicians to set up a patient on the Symphony™ for subsequent transfer and immobilization throughput in cancer treatments and other procedures. Qfix intends to market the Symphony™ Patient Transport System which consists of the Symphony™ trolley and several transfer surfaces including; a standard transfer surface, a head/neck transfer surface, and a brachytherapy solution which are compatible with existing patient positioning devices. The Symphony™ Patient Transport System is designed to optimize workflow efficiencies and improve patient outcomes.

The Encompass™ SRS Immobilization System provides noninvasive stereotactic head and neck immobilization by using a patient specific thermoplastic mask that conforms to the patient's features to provide accurate, reproducible positioning. a pationing and immobilization. The Encompass™ SRS Immobilization System allows the patient to undergo diagnostic imaging in the same position as that of the treatment position enabling more accurate radiation therapy.

The Encompass™ SRS Immobilization System is a highly advanced, non-invasive immobilization solution designed for precisely targeted brain, head and neck treatments. The Encompass™ SRS Immobilization System consists of a posterior support of either a Fibreplast™ thermoplastic mask, or a Moldcare cushion which rests on a contoured surface. The Encompass™ SRS Immobilization System features the IntegraBite™, which reduces motion allowing for maximum dose to the tumor while minimizing radiation delivered to the surrounding healthy tissue. The Integrated Shim System™ enables quick and seamless 0.5 mm height adjustments of the thermoplastic mask for a fully customizable patient setup. The Encompass™ SRS Immobilization System is designed to optimize workflow efficiencies and improve patient outcomes.