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The Auto Lung Nodule Detection is computer-aided detection software to identify and mark regions in relation to suspected pulmonary nodules from 10 to 30 mm in size. It is designed to aid the physician to review the PA chest radiographs of adults as a second reader and be used as part of S-Station, which is operation software installed on Samsung Digital X-ray Imaging systems. Auto Lung Nodule Detection cannot be used on the patients who have lung lesions other than abnormal nodules.

Auto Lung Nodule Detection is a Computer-Aided Detection (CADe) device that is designed to perform CAD processing in Chest X-ray images for indication of locations for high nodule probability, which has an effective detection sizes from 10 mm to 30 mm. Auto Lung Nodule Detection receives images acquired with SAMSUNG Digital X-ray Imaging Systems as an input and identifies suspected nodules, and then sends information of suspected nodules to the visualization part of S-Station, which is installed on all kinds of SAMSUNG Digital X-ray Imaging Systems, to generate output images with circular marks. The CAD performed images, are displayed on the screen by S-Station without defeat of original images and used as a second reader only after the initial read is completed.

The GC70 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. The GU60A & GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. GF50 Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. The GF50A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications. The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications. The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 are used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. An IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A. This submission is purposed to get 510(k) clearance for expanding the scope of the claim, cleared with K172229, from GC85A to the proposed devices, Samsung x-ray systems. The IPE, a software which has no relation with imaging chain, is applied to the proposed devices and it is evaluated that images acquired by a various imaging chain are substantially equivalent to GC85A in a non-clinical evaluation. The proposed devices with the IPE employing an advanced noise reduction algorithm are able to reduce dose of 50% for chest PA of average adult for marketing purpose. This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction.

The GU60A & GU60A-65 Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The GU60A & GU60A-65 digital X-ray imaging systems are to be used to take and store image for diagnosis of patients. It consists of HVG(High voltage generator), U-arm positioner, Detector, X-ray tube, Collimator, AEC(Auto Exposure Control), DAP(Dose Area Product), CIB(Control Interface Box), Remote controller, Grid, Barcode scanner and Autostitching stand. These systems are used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The GU60A & GU60A-65 digital X-ray imaging systems is stationary, and it was previously cleared under K151685. The software features cleared with K171119, SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement), is added to the predicate x-ray system (K151685). The software features called as SimGrid, BSI (Bone Suppression Image) and TLE (Tube & Line Enhancement) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The SimGrid software option is able to compensate the contrast loss due to scatter radiations, primarily acquisitions without a physical anti-scatter grid. The BSI software option suppresses bone anatomy and the TLE software option enhances visibility of tube and catheter features in a companion image that is delivered in addition to the original diagnostic image. These software features are designed to be exclusively installed in S-station, SAMSUNG digital X-ray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.

The GC85A Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The GC85A digital X-ray imaging system is used to capture images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The Image Post-processing Engine is exclusively installed in S-station, which is a Samsung Digital X-ray Operation Software for Samsung Digital X-ray System. It has an image processing algorithm to improve an acquired image and previously cleared with K160997. The proposed Image Post-processing Engine is upgraded with employing an advanced noise reduction algorithm to improve image quality. The proposed Engine is shown of a post-processed image as substantially equivalent as the image by the predicate Image Post-processing Engine at a certain low dose level.

The GM85 Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

The GM85 Digital Mobile X-ray imaging System is the equipment that captures images by transmitting X-ray to a patient's body. The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images. The Bone Suppression Image (BSI) is a post-image processing software option which provides companion images to assist diagnosis in addition to the images obtained from normal diagnosis protocol. The BSI software option suppresses bone anatomy to enhance visualization of chest pathology in a companion image that is delivered in addition to the original diagnostic image. The BSI option is designed to be exclusively installed in S-station, SAMSUNG digital Xray operation software, while it uses the radiological image as an input and do not depend on how the image is acquired or which radiology device is used.