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The System is intended for use in Radiographic / Fluoroscopic applications including general radiographic / fluoroscopic diagnostic, and interventional X-Ray imaging for General and Pediatric Populations.

The Soteria E-View system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria E-View interventional fluoroscopic X-ray system consists of: - The patient table and C- arm with X-ray source on one side and the flat panel detector on the opposite side. The C-arm can be angulated in both planes, and the flat panel detector can be lifted vertically. The tabletop can be shifted from side to side and move forward/backward by an operator. - Real-time image visualization of patient anatomy during procedures. - Imaging techniques and tools to assist interventional procedures. - . Post-processing functions after interventional procedures. - Storage of reference/control images for patient records. - Compatibility to images of other modalities via DICOM. - . Built-in radiation safety controls-with the already FDA cleared CA-100S /FluoroShield (K182834). This array of functions provides the physician with the imaging information required to achieve minimally invasive interventional procedures. The Soteria E-View system is available as a Model GI-100 configuration. It is similar to the currently marketed predicate Soteria.Al consisting of an X-ray generator, image processor, collimator, X-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K212336).

The Omega Medical Imaging, LLC Nyquist.IQ Image Processor is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP Systems.

Nyquist.IQ is a dynamic digital image processing system. The system application is based on a PC Windows operating system functioning on a PC based CPU. The object-oriented software performs real-time image processing and full procedure storage. The DICOM compliant connectivity provides the tools to transmit patient demographics, examination, and image data digitally. Nyquist.IQ is not a standalone device, but functions as a component for FDA cleared Omega CS-series-FP platform. Nyquist IQ is an image processor that interfaces, with to acquire and digitize x-ray exposure from the Omega medical CS-series-FP. The Nyquist.IQ operates in connection with the Varex's 3030 or the Teledyne 3030 flat panel detectors. This is demonstrated in the substantial equivalence section of the Nyquist.IQ is intended for the Omega CS-series-FP with Optional Accessory Device CA-100S / FluoroShield platform. The Nyquist.IQ is intended solely to be integrated only with Omega Medical Imaging CS-series-FP systems. The Nyquist.IQ image processor. The fundamental performance characteristics of the Nyquist.IQ interventional fluoroscopic imaging Processor system consists of: - ) Real-time image visualization of patient anatomy during procedures - > Imaging techniques and tools to assist interventional procedures. - 2 Post-processing functions after interventional procedures. - 2 Storage of reference/control images for patient records. - Σ Compatibility to images of other modalities via DICOM - 2 Compatibility with the already FDA cleared CA-100S / FluoroShield AI Exposure Reduction Technology. (K182834) This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures. The Nyquist.IQ image processor is available as a Model IPS-100 configuration and is similar to the currently marketed and predicate image processor MX-200 in CS-series-FP with optional CA-100S / FluoroShield Device.

The System is intended for use in Radiographic/fluoroscopic applications including cardiac, general radiographic/fluoroscopic diagnostic and interventional x-ray imaging for General and Pediations

The Soteria.Al system is classified as an interventional fluoroscopic X-ray system. The fundamental performance characteristics of the Soteria.AI Interventional fluoroscopic X-ray system consists of: - The patient table and c- arm with X-ray source on one side and the flat panel detector on the opposite side. The c-arm can be angulated in both planes, lifted vertically, shifted to the side, and moved forward/backward by an operator. - Real-time image visualization of patient anatomy during procedures - Imaging techniques and tools to assist interventional procedures. - Post-processing functions after interventional procedures. - Storage of reference/control images for patient records. - Compatibility to images of other modalities via DICOM - Built-in radiation safety controls-with the already FDA-cleared CA-100S / FluoroShield (K182834) This array of functions provides the physician the imaging information required to achieve minimally invasive interventional procedures. The Soteria.Al system is available as a Model Al-100 configuration. It is similar to the currently marketed predicate consisting of an X-ray generator, Image processor, collimator, x-ray Tube, Positioner, and patient table with CA-100S / FluoroShield Accessory, (K182834). Additionally, Soteria.Al can be equipped with an optional X-ray VVA (Vessel and Ventricular Analysis) image analysis (FDA-Cleared) software, (K112807).

The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that reduces exposure to the patient and operator. The system is intended for use in Radiographic/fluoroscopic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest

This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S / FluoroShield™ K182834 cleared 02/18/19). The CA-100S/ FluoroShield™ will be used with the following FDA cleared device: Omega's CS-series-FP ( K100102) which utilizes a Varex 2020 Flat Panel Detector. (Note: the only difference between this submission and the predicate is the size of the FPD. The predicate device utilizes a Varex 3030 Flat Panel Detector) The-CA-100S/ FluoroShield™ system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor. The CA-100S / FluoroShield™ is a secondary collimator that can only be used in conjunction with the primary collimator. When using the CA-100S / FluoroShield™, the primary collimator shall be used to manually define a region of interest. Once this ROI has been established by the primary collimator, the CA-100S / FluoroShield™ can be used to further reduce the size of the ROI beyond the ROI initially established with the primary collimator.

The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that manages exposure to the patient and operator. The system is intended for use in Radiographic applications including cardiac, vascular, general radiographic/ fluoroscopic diagnostic, and interventional x-ray imaging for General Populations. At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest

This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S). The CA-100S will only be used with the following FDA cleared device: Omega's CSseries-FP ( K121293). The-CA-100S system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor. Omega's (CA-100S) allows for auto collimation while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy of ROI + background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures. The CA-100S secondary collimator may be used to additionally shield anatomy that is not the primary focus of the physician but is required to maintain peripheral imaging. The CA-100S ROI image processing combines the live ROI with the legacy image of the full field of view (defined by the primary collimator). This allows for the collimation of the ROI without impacting the doctors normal work flow, visualisation, orientation and navigation. The Product is permanently incorporated in the host fluoroscopy system (Omega's CS-series-FP) and its clinical environment. The system is intended to be installed by trained technicians and operated by professionals trained in its use and the associated medical interventional procedures. The CA-100S Product functions in ON Mode, OFF Mode or Bypass Mode. The Product consists of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor with Status / Reduction Monitor and two ROI Control Panels.

The Omega Medical Imaging, LLC CS-series-FP (SSXI) Systems are intended for use in Radiographic/fluroscopic applications including cardiac, vascular, general radiographic/fluroscopic diagnostic, and Interventional x-ray imaging.

The Omega Medical Imaging, LLC, CS-series-FP systems currently incorporate a 19.8cm x 19.8cm or 29.8cm x 29.8cm solid-state flat-panel detector (FPD). This 510(k) submission adds a slightly larger 21.7cm x 21.7cm and 30.3cm x 30.3cm solid-state CMOS flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted c-arm and patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The MX CFP 3131 flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system (separate from the Flat Panel Detector) which includes image processing, viewing functions, local storage, and DICOM compatibility. The Image Processor does not have the capability to connect to the internet as there is no browser. Subject Device Flat Panel Detectors MX CFP 2222 / 3131 are to be used only with the Omega CSseries-FP Fluoroscopic Systems

The Omega Medical Imaging, LLC CS-series-FP with 3030+ Option systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.

The Omega Medical Imaging, LLC. CS-series-FP systems currently incorporate a 19.8cm x 19.8cm solid-state flat-panel detector (FPD) as an option. This 510(k) submission adds a larger format (29.8cm x 29.8cm) flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-arm and a patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.