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DIGITAL RADIOGRAPHY CXDI-RF Wireless B1 is indicated for use in generating radiographic images of human anatomy to replace the radiographic film/screen systems in all general purpose diagnostic procedures. It is also used for generating fluoroscopic images, when integrated into the X-ray diagnostic systems, to replace the spot-film devices and the X-ray image intensifiers. Not intended for mammography applications.

The proposed CXDI-RF Wireless B1 is a solid state X-ray imager, which is capable of both fluoroscopic and spot radiographic imaging and has a common Thallium-doped Cesium Iodide (CsI:TI) scintillator. The CXDI-RF Wireless B1 will be integrated as a component into the Canon fluoroscopy x-ray system for fluoroscopic and radiographic imaging. The CXDI-RF Wireless B1 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software (CXDI Controller RF version 3.11), and then displayed on the PC/monitors. The PC/monitors used with the CXDI-RF Wireless B1 are not a part of this submission.

The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors and, in the predicate device submission (K222661), consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, CXDI-410C Wireless, DIGITAL RADIOGRAPHY CXDI-Pro (CXDI-703C Wireless and CXDI-403C Wireless), and DIGITAL RADIOGRAPHY CXDI-Elite (CXDI-720C Wireless). The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission. The subject of this Special 510(k) submission is the changes to the predicate CXDI-CS01, which include the addition of the DIGITAL RADIOGRAPHY CXDI-Pro detector (CXDI-803C Wireless) and the DIGITAL RADIOGRAPHY CXDI-Elite detectors (CXDI-820C Wireless and CXDI-420C Wireless) to the CXDI-CS01 series of detectors, a firmware update of the DIGITAL RADIOGRAPHY CXDI-Pro and DIGITAL RADIOGRAPHY CXDI-Elite detectors from 01.01.03.00 to 01.02.00.01 and from F2.00.03.00 to 02.01.04.00 respectively, and a CXDI Control Software version update from V3.10.2.2 to V3.10.2.6 to fix bugs. Together, these changes make up the CXDI-CS01.

The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector (also called the AR-E3543W detector), the CXDI- 420C Wireless detector (also called the AR-E4343W detector), and the CXDI-420C Fixed detector (also called the AR-E4343S detector). The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-Elite are not a part of this submission. The proposed changes to the predicate device, DIGITAL RADIOGRAPHY CXDI-Elite (K221620), include the addition of a new detector, the CXDI-820C Wireless (also called the AR-E2735W), to the CXDI-Elite series; the standardization of the thickness of CXDI-720C Wireless and CXDI-420C Wireless; the firmware update from F2.00.03.00 to 02.01.04.00; the CXDI Control Software version update from 3.10.2.2 to 3.10.2.6; and the addition of a 25 m of the CXDI-420C Fixed detector cable and a 10 m of Wiring Cable (WC-01). Together, these changes make up the CXDI-Elite.

The DIGITAL RADIOGRAPHY CXDI-CS01 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-CS01 (hereinafter referred to as CXDI-CS01) is a solid-state x-ray imager. The CXDI-CS01 is a series of detectors, and in the predicate device (K203849) consists of the CXDI-702C Wireless, CXDI-402C Wireless, CXDI-710C Wireless, CXDI-810C Wireless, and CXDI-410C Wireless. The CXDI-CS01 intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values. The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors. The PC/monitors used with the CXDI-CS01 are not a part of this submission. The subject of this Special 510(k) submission is a change to the CXDI-CS01 to add the DIGITAL RADIOGRAPHY CXDI-Pro (hereinafter referred to as CXDI-Pro) series and the DIGITAL RADIOGRAPHY CXDI-Elite (hereinafter referred to as CXDI-Elite) series detectors to the CXDI-CS01 series of detectors. In addition, the CXDI-Pro and CXDI-Elite components and features (Bluetooth connection and the Built-in AEC Assistance) have been added to the CXDI-CS01. The CXDI Control Software has been updated from V2.19.0.7 to V3.10.2.2 to add the Intelligent NR function (cleared under K212269), update the GPU driver, add several minor functional changes, and fix bugs. Together, these changes make up the CXDI-CS01.

The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device (K220098) consists of the CXDI-703C Wireless and CXDI-403C Wireless detectors, also called the AR-D3543W and AR-D4343W detectors respectively. The detectors intercept x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values The digital values are sent to the PC via a wired or wireless connection, converted to images with the CXDI Control Software, and then displayed on the PC/monitors The PC/monitors used with the CXDI-Pro are not a part of this submission. The subject of this Special 510(k) submission is a change to the predicate device, including compatibility with the Multi Box and Status Indicator, DIGITAL RADIOGRAPHY CXDI-Elite components that were cleared under K213780. The Status Indicator can be used when the proposed device is used in combination with the Multi Box. In addition, the CXDI Control Software has been updated from V3.10.0.8 to V3.10.2.2 to fix some bugs. Together, these changes make up the CXDI-Pro.

The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager. The CXDI-Elite is a series of detectors, and in the predicate device consists of the CXDI-720C Wireless detector unit, also called the AR-E3543W detector. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values, and the images will be displayed on monitors. The digital value can be communicated to the operator console via a wired or wireless connection. The subject of this Special 510(k) submission is a change to the CXDI-Elite to add new detectors, the CXDI-420C Wireless (also called AR-E4343W) and the CXDI-420C Fixed (also called AR-E4343S), to the CXDI-Elite series of detectors. In addition, a Detector Stand (DS-01) has also been added as a component to be used with both the CXDI-720C Wireless and CXDI-420C Wireless. Compatibility with the Power Box (PB-01), a CXDI-Pro component that was cleared under K220098 has also been added. The CXDI Control Software has been updated from V3.10.0.4 to V3.10.2.2 to fix some bugs, update the GPU driver, and add several minor functional changes. Together, these changes make up the CXDI-Elite.

The DIGITAL RADIOGRAPHY CXDI-Pro / D1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Pro, also called the DIGITAL RADIOGRAPHY D1, (hereinafter referred to as CXDI-Pro) is a solid-state x-ray imager. The CXDI-Pro is a series of detectors, and in the predicate device consists of the CXDI-703C Wireless detector unit, also called the AR-D3543W detector. The detector intercepts x-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to digital values, and the images will be displayed on monitors. The digital image can be communicated to the operator console via a wired or wireless connection. The subject of this Special 510(k) submission is a change to the CXDI-Pro add a detector, the CXDI-403C Wireless (also called AR-D4343W) to the CXDI-Pro series of detectors. In addition, a Detector Stand (DS-01) and a new Battery Charger (BC-01) have been added as optional components to be used with the proposed CXDI-Pro detectors (CXDI-703C Wireless and CXDI-403C Wireless), the sleep to ready cycle time for the proposed CXDI-Pro detectors has been decreased, and the CXDI Contro Software has been updated from V3.10.0.3 to V3.10.0.8 to add the Intelligent NR function (cleared under K212269) and apply some bug fixes. Together, these changes make up the CXDI-Pro.

The DIGITAL RADIOGRAPHY CXDI-Elite / E1 provides digital image capture for conventional film/screen radiographic examinations. This device is intended to capture, for display, radiographic images of human anatomy, and to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The DIGITAL RADIOGRAPHY CXDI-Elite, also called the DIGITAL RADIOGRAPHY E1, (hereinafter referred to as CXDI-Elite) is a solid-state x-ray imager using TFT (thin-film transistor) arrays. The CXDI-Elite is a series of detectors, currently consisting of the CXDI-720C Wireless detector unit, also called the AR- E3543W detector. The detector intercepts x-ray photons, and the Cesium-Iodide scintillator emits visible spectrum photons that illuminate an array of photodetectors that create electrical signals. After the electrical signals are generated, the signals are converted to a digital image, and the images will be displayed on monitors. The digital image can be communicated to the operator console via a wired or wireless connection. The monitors used with the CXDI-Elite are not a part of this submission. The CXDI Control Software is updated from V2.16 to V3.10 in this submission. The update to the software includes bug fixes, modification to check-in function, modification to communication with X-ray emission devise, calibration support, addition of the Intelligent NR function (previously cleared under K212269), and the addition of Standard Synchronization Mode with Built in AEC Assistance.

As a part of the Canon radiography system, the CXDI Control Software when used with a compatible Canon detector is intended to provide digital image capture, processing, and display for conventional film/screen radiographic examinations. This device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures including specialist areas like intensive care, trauma, and pediatric work. This device is not intended for fluoroscopic, angiographic, or mammography applications.

The Intelligent NR (Intelligent Noise Reduction) function is a part of the CXDI Control software for the Canon detectors (with version 3.10 of the CXDI Control Software) that makes use of the Intelligent NR function to reduce noise for X-ray images taken using the Canon detectors. The Intelligent NR function was developed using machine-learning and trained by using an existing clinical image database to learn the characteristics of noises and create noise reduced images. The Intelligent NR function does not perform machine learning after release to users. The CXDI control software, which Intelligent NR is a part of, provides system control, controls GUI on the monitor, and processes images. The Intelligent NR function works on a PC and displays to a monitor. The Intelligent NR function is used in conjunction with the cleared Canon detectors compatible with CXDI Control Software V3.10. The firmware within compatible Canon detectors to be used with this device is unchanged, and no firmware update is necessary for compatibility with the Intelligent NR.