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This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures). Not for mammography.

The Halifax SR Suite consists of two X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability. The Halifax Imaging Kit is part of the SR Suite product line and provides an alternative path to creating an SR Suite. The Halifax Imaging Kit consists of FDA cleared and/or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing Digital Radiography (DR) system are synchronized by replacing the trigger switches of the two systems with either the Universal Synchronization Switch or the Imaging Kit Control Module (IKCM). The Universal Synchronization Switch or IKCM ensures the two X-Ray imaging systems fire simultaneously, therefore providing a pair of X-Ray images from two different perspectives taken at the exact same time. There are two versions of the Halifax Imaging Kits: a) UNIVERSAL SYNCHRONIZATION (NON-GE BASED CONFIGURATION) The Universal Synchronization Switch synchronizes two independent X-ray systems as accurately as possible by using the manual pushbutton interface of each X-ray system. This replaces the synchronization switch that was described in our predicate K121345. b) IMAGING KIT CONTROL MODULE (GE BASED CONFIGURATION) The general purpose of the IKCM is to coordinate and control the activities of the detector and workstation with the activities of the generator, as well as coordinate the exposures between the client's clinical system and the Halifax Imaging Kit for RSA exposures. The current version of the IKCM is designed specifically for interfacing with the following components: •GEHC WDR1 Upgrade Kit which consists of a 'Flashpad' detector, a workstation named 'MagicPC', and a 'Cabinet' for power distribution and communication control. Integrating with a pre-existing system (GEHC Discovery XR656 Plus). · EMD Technologies Epsilon Series generator. (Or generators already on site)

Orthopaedic specialists and/or Halifax Biomedical Inc image processing labs use the Model-based RSA Software as standalone analytical software package for the evaluation of orthopaedic implant fixation , bone segment motion. Model-based RSA software measures the in-vivo 3D position and/or relative motion of metal implants, marker beads, and/or bone segments. When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment. NOT FOR MAMMOGRAPHY.

This is a Windows based software only product. It represents an advancement and extension of the same software cleared in K042383. Model-based RSA (Roentgen Stereophotogrammetric Analysis) is a stand-alone analytical software package for RSA digital image post-processing that runs on standard workstations running a Microsoft Windows operating system. This software is used to analyze roentgen images. It accepts digital images in the specific formats from all the major roentgen manufacturers (DICOM - CR and DX modality) as well as scanned roentgen films in bitmap (BMP) format. Generally, a pair of stereo roentgen images is taken of a patient's joint pre-operatively or postoperatively at one or more time points. Model-based RSA software is then used to measure the three dimensional (3D) relative position and/or relative motion of 3D models in the RSA images. Models may generally represent orthopaedic implants, a group of implanted markers (small tantalum beads), or bones. The 3D relative position and/or relative motion measures may provide information regarding of implants, wear of implants, and excessive or reduced motion between bones such as in spine instability and spine fusion

This is a stationary digital x-ray system for general radiography and RSA (Roentgen Stereophotogrammetric Analysis procedures.) Not for mammography.

The Halifax SR Suite is compromised of two regulatory approved X-Ray imaging systems; the two systems are integrated through a synchronization switch. The switch allows the two X-Ray imaging systems to fire simultaneously, providing a pair of X-Ray images from different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA). RSA is a stereo x-ray technique that enables measurements more precise than single plane radiography based on phantom precision studies. The resulting level of precision provides measurements of joint replacement stability. The components are: 1: Stand. 2: Tube housings, 3: Collimators, 4: Reference Box Cover, 5: SR reference box, 6: Detector Plates, 7: SR Support Arm. The SR Suite employs the software cleared in K042383, the RSA-CMS.

Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. The tantalum beads are used as radio opaque markers that are implanted in bone or soft tissue. The tantalum beads are used to measure changes in position of prostheses and anatomical structures with the aid of x-ray images. The tantalum beads are implanted with a manual instrument. The tantalum beads are provided in a cartridge (set of 16 beads, "The tantalum Bead Set") that is inserted into the manual instrument. The instrument inserts one Tantalum bead via manual activation by the surgeon. The Tantalum Bead Set is provided in the sterile condition; sterility is achieved by means of gamma radiation with a sterility assurance of 10 to the power of -6 SAL.

Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an xray system. Implant surgery associated with the use of radiographic markers may include total joint replacement procedures, soft tissue repair and bone fracture fixation procedures.

The Tantalum Bead Set consists of 1mm spherical x-ray markers made of commercially pure, unalloyed tantalum. They are used as radio-opague markers and may be implanted into bone or soft tissue. These devices are used to measure movement of implants after surgery with the aid of an x-ray. The beads are applied with a manual surgical instrument. The beads are provided non-sterile in a cartridge which includes 16 beads. The cartridge, manufactured from PEEK is designed to be used with the Halifax RSA Bead Inserter (Class 1 device) to allow surgeons to deploy the beads into the bone and tissue surrounding an orthopaedic implant. The inserter and cartridge containing the beads must be sterilized by the hospital prior to use.