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The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) – Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option indication for Arineta's SpotLight and SpotLight Duo scanners is being expanded to include small patients, as defined by AAPM (American Association of Physicists in Medicine). This expansion ensures comprehensive coverage of the intended lung cancer screening population, following the previous clearance of the LD LCS option for medium and large patients under K241200. The proposed LD LCS option for the SpotLight and SpotLight Duo includes scan protocols with CTDI that comply with AAPM's requirements for the whole LD LCS population patient size groups, as detailed in the following table: | Patient Size (AAPM group) | Weight (Kg) | CTDI (mGy) | SpotLight / SpotLight Duo - Indication for Use | |---|---|---|---| | Small | 50-70 Kg | 0.25-2.8 mGy | Proposed Device | | Medium | 70-90 Kg | 0.5-4.3 mGy | K241200 | | Large | 90-120 Kg | 1.0-5.6 mGy | K241200 | There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied. The proposed full LD LCS protocols option, as the cleared K241200, will be activated by service or production personnel, with no additional installation required (option activation only).

The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465). There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied. This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening. No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics: • Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions. · Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only).

SpotLight /SpotLight Duo (with DLIR option) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, in a single rotation. The system may acquire data using Axial, Cine, and Cardiac scan techniques from patients of all ages (DLR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field of view. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight / SpotLight Duo (with DLIR option) is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software and software for operator interface and image handling. The Deep Learning Image Reconstruction (DLIR) algorithm is a deep learning technology-based software sub-system that is integrated into the image reconstruction software. As in other CT scanners, a scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation of the radiation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight Duo is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling. As in other CT scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

The SpotLight CT Computed Tomography X-ray is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of organs that fit in a 25cm field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight CT is a third generation rotate-rotate CT scanner, designed and built based on technologies and principles of operation of the predicate device and other legally marketed CT scanners. The SpotLight CT is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling.