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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.

The GM85 Digital Mobile 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images. The GM85 Digital Mobile X-ray imaging System was previously cleared with K222353, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a detector, accessories are newly added and software is updated for user convenience. The new detector added in the proposed device is designed to achieve a higher IP rating of Dust and Water and reduce weight while maintaining durability, functionality and operation like the detector of the predicate device. The new detector and predicate device's detector are both an x-ray conversion device using an amorphous silicon flat panel and absorb incident x-rays, converts it to a digital signal, and then transmits it to the Samsung Digital X-ray System like that of the predicate device.

The GF85 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 GF85 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 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. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.

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.

The GM85 Digital Mobile 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images.

The GEMS-H is a robotic exoskeleton that fits orthotically on the wearer's waist and thighs, outside of clothing. The device is intended to help assist ambulatory function in rehabilitations under the supervision of a trained healthcare professional for the following population: · Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4 m/s and are able to walk at least 10 meters with assistance from a maximum of one person. The trained healthcare professional must successfully complete a training program prior to use of the device. The device is not intended for sports.

The GEMS-H is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stroke patients who meet the assessment criteria, in rehabilitations under the supervision of a trained healthcare professional. The GEMS-H device provides assistance to the patient during hip flexion and extension. The device is worn over clothing around the wearer's waist and fastened with Velcro straps to assists hip flexion and extension. The device weighs 4.7 lbs (2.1 kg) and has two motors that run on a single rechargeable battery. The device is equipped with joint angle and electrical current sensors to monitor hip joint angle and torque output, respectively. The assist torque is transmitted to the wearer's thighs via thigh support frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on the tablet PC.

The CUBE Air Purifier is a device intended for medical purposes that is used to destroy bacteria and viruses in the air by exposure to ultraviolet radiation. The CUBE Air Purifier has been demonstrated to destroy the following MS2 bacteriophage, Staphylococus epidermidis, Escherichia coli entrained on the filter of the under the following exposure conditions: | Organisms | Name | Average Maximum log reduction/<br>exposure time (hours) | | |-----------|----------------------------|---------------------------------------------------------|--| | | | Room temperature test | | | Virus | MS2 bacteriophage | 5.33±0.23 /60 mins | | | Virus | Phi-X174 bacteriophage | 5.34±0.11 /60 mins | | | Bacteria | Staphylococcus epidermidis | 5.36±0.28 /60 mins | | | Bacteria | Escherichia coli | 5.17±0.05 /60 mins | |

The CUBE Air Purifier employs a photocatalytic oxidation (PCO) ultraviolet air purification technology that destroys bacteria and viruses in air in medical facilities. The CUBE Air Purifier includes a pre-filter, a dust collecting filter, UV-A LED lights (320-400 nm), and a catalytic filter. The device is intended to be placed in medical and healthcare facilities.

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 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. The 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, GM85 and GC85A 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, SAMSUNG digital X-ray operation software, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. The 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 (hereinafter "new IPE") 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 (hereinafter "old IPE"), is substantially equivalent.

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 GC70 digital X-ray imaging system is a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray 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. The GC70 digital X-ray imaging system consists of HVG (High Voltage Generator), ceiling suspension, X-ray tube, collimator, detector, wall stand, patient table, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, foot switch, barcode scanner, auto-stitching stand, weight distribution cap and workstation for S-station including Image Post-processing Engine (IPE). The GC70 digital X-ray imaging system was previously cleared under K180543, and some hardware options and three software features are added to the predicate device GC70. The changes are as follows: - Two High Voltage Generators - . Two detectors - . Slim wall stand - . Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View - The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process. - Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients. - The Remote view function provided images on another PC, not just on the device.

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 a stationary x-ray system designed for general radiography and 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 Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images. The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE). The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65. The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows: - Two detectors - Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View - The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process. - Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients. - The Remote view function provided images on another PC, not just on the device.

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.

The GM85 Digital Mobile 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 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 send to the Picture Archiving & Communication System (PACS) sever for reading images. The GM85 Digital Mobile X-ray imaging System was previously cleared with K180543, and through this premarket notification, we would like to add more configurations in the previously cleared GM85 as a fixed column type and two detectors are newly added, and three software features are newly added as stated below. S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Manual Stitching to capture a body part that is larger than the detector's by capturing multiple images and Remote View function to remote access to view the current image on the workstation through a web browser. It was determined that the level of concern for the software contained in the GM85 Digital Mobile X-ray imaging System was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".

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 a stationary x-ray system designed for general radiography and used to capture images by transmitting X-ray to a patient's body. The Xray 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. The GC85A digital X-ray imaging system was previously cleared with K172229, and through this premarket notification, we would like to add more configurations in the previously cleared GC85A as three High Voltage Generators and two detectors are newly added, and three software features are newly added as stated below. S-Enhance is renamed from Tube & Line Enhancement (TLE), which was cleared before with the predicate device GM85 at K171119, to enhance visibility of tubes and lines and provide enhanced images separately from original images. In this submission, the scope of S-Enhance is expanded from tubes and lines on chest images to foreign body (e.g. tubes, lines and needles) and urinary stones on chest, abdomen, and L-spine. And Pediatric Exposure Management (PEM), which was cleared before with the predicate device GM85 at K171119, is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols, and Remote View to enable the images on the device is being displayed on the remote monitor. It was determined that the level of concern for the software contained in the GC85A digital X-ray imaging system was Moderate in accordance with the FDA guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Device".