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The ControlRad® Select Model Z with the Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z 's region of interest (ROI) as compared to Artis zee non-collimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, bv image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. 1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system. The ControlRad® Select Model Z consists of a ControlRad® filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad® filter is installed semipermanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures. The ControlRad® Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad® Select Model Z is only compatible with the 30 x 40 detector and associated collimator. Use of this system on other sizes is prohibited. The additional radiation reduction provided by the ControlRad® Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV. The main components of the ControlRad® Select Model Z which are used with the Artis zee are: - ControlRad® Tablet . - ControlRad® Filter . - ControlRad® Hardware ● - ControlRad® Software and Firmware Modules . - . ControlRad® Communication Interface The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3.0 mm, both of which are partially transparent to X-ray radiation.

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angography and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. The ControlRad® Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. The ControlRad® Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC® 9800/OEC® 9800 Plus non-collimated image area. The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

**ControlRad® Select Model Z Device Description:** The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system. It consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi-permanently to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures. The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV. The main components are ControlRad Tablet, ControlRad Filter, ControlRad Hardware, ControlRad Software and Firmware Modules, and ControlRad Communication Interface. ControlRad® Select Model Z contains a titanium filter (2.5mm or 3mm nominal thickness). The system allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-tranium filters to deliver the designed high-quality image. **ControlRad® Trace Model 9 Device Description:** The ControlRad® Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad® Trace Model 9 is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad® Trace Model 9 components are installed semi-permanently in the cleared GE Healthcare Surgery's OEC® 9900 Elite (K122234) and operate in parallel to the GE Healthcare Surgery's OEC® 9900 Elite. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI. **ControlRad® Trace Model 8 Device Description:** The ControlRad® Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad® Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Trace's region of interest (ROI) as compared to the OEC 9800/OEC 9800 Plus non-collimated image area. The ControlRad® Trace Model 8 consists of the following main components: ControlRad ("CR") Trace Tablet, CR Trace Filter, CR Hardware, CR Software and Firmware Modules and CR Communication Interface. The ControlRad® Trace Model 8 components are installed semi-permanently on the cleared GE Healthcare Surgery's OEC® 9800 Plus (K132027) and operate in parallel to the GE Healthcare Surgery's OEC® 9800 Plus. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9800 Plus's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI.

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee non-collimated image area.1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image quided surgery by Xray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. 1Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system. The ControlRad® Select Model Z consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semipermanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures. ControlRad® hereby submits this Traditional 510(k) to request clearance to market the ControlRad® Select Model Z with SW version V1.0.0.7.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV). The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited. The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV. The main components of the ControlRad® Select Model Z which are used with the Artis zee are: - ControlRad Tablet - ControlRad Filter - ControlRad Hardware - ControlRad Software and Firmware Modules - ControlRad Communication Interface The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's reqion of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3mm, both of which are partially transparent to X-ray radiation. Based on the user selection of the Artis zee collimator the ControlRad Filter region of interest (ROI) the radiation will be reduced. The X-ray beam inside the ROI is not impacted by the ControlRad Filters. All radiation outside the ROI and inside the Artis zee collimated area will be filtered. This can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. The ControlRad® Select Model Z allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-transparent titanium filters to deliver the designed high-quality image. This allows the Artis zee to generate an image in the selected physician's ROI while providing a lower radiation dose to the periphery. The result is a reduction in the overall radiation dose and exposure to the patient and the healthcare team while providing the physician the contextual information needed outside the ROI. The workflow is therefore supported with lower radiation than with conventional imaging settings. The ControlRad Filter is designed to always include the center of the FOV in the ROI. Therefore, when selecting an ROI by the user, the actual ROI might be expanded to include the center of the FOV. The ControlRad® Select Model Z is a product that can be mounted only on the following configurations of the Artis zee: floor, ceiling, and bi-plane systems.

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 is a system used to assist trained clinicians which is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

ControlRad Sterile Cover is a single use sterile equipment cover intended for use by professionals in a sterile clinical setting to cover the ControlRad Trace Tablet and create a sterile barrier between the rest of the sterile field to prevent contamination during various procedures.

The ControlRad Sterile Cover is a terminally sterilized device intended to cover the ControlRad tablet in order to operate a ControlRad tablet in a sterile environment.

The ControlRad™ Trace Model 8, when used with OEC® 9800/OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC® 9800/OEC® 9800 Plus non-collimated image area. The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

The ControlRad™ Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad™ Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9800/OEC 9800 Plus non-collimated image area. The ControlRad™ Trace Model 8 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. The ControlRad™ Trace Model 8 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface.