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DVAS is an extra-oral source x-ray system to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic dental radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors. It is intended for both adult and pediatric subjects.

DVAS, the extra-oral source x-ray system for dentistry is the standard X-ray equipment used to acquire intraoral images of patients during dental diagnosis such as dental caries, periodontal diseases, dental root fracture, and other oral and dental pathologies. DVAS is used to provide anatomic X-ray images of a patient at hospitals or dental clinics using a cone for X-ray exposure. The doctor or dentist can check the acquired X-ray images with chemical films or a PC monitor. DVAS can be used Digital I/O Sensor, Image plate (CR), Film as a Image receptor. The image receptors are not part of this submission.

GenX-CR is a digital radiographic scanner for dental diagnostics intended for use by dentists and other qualified professionals. This device is used to create and display digital images by scanning intraoral X-ray images stored in an Image Plate (or Phosphore Storage Plate).

GenX-CR scans a reusable phosphor storage plate (hereinafter referred to as "PSP") instead of an analog film to acquire high-quality digital radiographic images, digitally processes them, and displays images on the equipment's touch display screen and computer screen. It's a scanner. PSP is also known as IP (Image Plate) After scanning the PSP, the image is saved in the device's internal memory, the scanned image can be checked in advance through the touch display, and the image stored in the PSP can be deleted and the PSP can be ejected. Scanned images can be directly transmitted to a computer or network via an Ethernet cable and are used in PortView, a dental diagnostic software package, and other diagnostic software. GenX-CR is composed of mainly consists of PSP Scanner, PSP tray, power adapter and cable, Ethernet cable, PSP transfer box, PSP, PSP Protective Cover, Hygenic Bag, Dental PSP scanner control system software (Version: V2.2) GenX-CR contains firmware that is part of the system. And we hereby certify that the level of concern for this software(PortView) and firmware(GenX-OP) is of Moderate level of concern. And It has not been cleared with other predicate devices but is the initial used in GenX-CR Its compact design allows installation in space-constrained locations and minimizeds operating costs by using a low-cost, reusable PSP.

OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15i are indicated only for adult patients.

The OSCAR 15 & OSCAR 15i, C-Arm Mobile are used for providing fluoroscopic and radiographic images of patient anatomy, especially during special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films. These devices are intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)

PAPAYA 3D & PAPAYA 3D Plus are digital panoramic, cephalometric and tomographic extra-oral X- ray systems, indicated for use in: (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm (Only for PAPAYA 3D Plus); (ii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The systems accomplish tomographic exam by acquiring a 360-degree rotational X- ray sequence of images and reconstructing a three-dimensional matrix of the examined volumensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

PAPAYA 3D & PAPAYA 3D Plus are diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. Also, PAPAYA 3D & PAPAYA 3D Plus are designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures. The difference between PAPAYA 3D & PAPAYA 3D Plus is only optional of the cephalometric detector. Without cephalometric detector, we name model PAPAYA, and with cephalometric detector, we name model PAPAYA Plus. Due to this difference, the cephalometric image acquisition function applies only to PAPAYA 3D Plus, not to PAPAYA 3D. PAPAYA 3D Plus is equipped with extra-oral flat panel x-ray detectors which is based on CMOS digital X-ray detector and has CT, panoramic and cephalometric radiography with an extra-oral x-ray tube. CMOS Flat panel detectors are used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D diagnostic images of the anatomic structures by acquiring 360ºrotational image sequences of oral and craniofacial area. The differences from predicate device (K150354) are change of power voltage, addition of image processing software (Theia, Triana).

PAPAYA & PAPAYA Plus are digital extraoral source X-ray system intended to produce panoramic and cephalometric(option) images of the oral and craniofacial anatomy for a precise treatment planning in adult and pediatric care. The system is used for dental & skull radiographic examination and diagnosis of teeth, jaw, oral structure, and skull by exposing an X-ray image receptor to ionizing radiation, with a digital imaging capability for taking both panoramic and cephalometric images. And This system can be equipped cust(Tomographic) option, which is capable of taking crosssectional radiographic images provide dimensional information for dental implant planning and information about location of impacted teeth.

The proposed devices PAPAYA & PAPAYA Plus are diagnostic imaging system which consists of multiple image acquisition modes; panorama and cephalometric. The difference beteween PAPAYA & PAPA YA Plus is only optional of the cephalometric detector. (Without cephalometric detector, we model named PAPAYA, and with cephalometric detector, we model named PAPAYA Plus.) The proposed devices have the CUST imaging option which is used to reconstruct tomographic images from a set of pre-acquired projection radiographic images of the object. The differences from predicate device(K141700) are change of power voltage, addition of image processing software(Theia, Triana).

ZEN-2090 Turbo, C-Arm mobile is used for providing fluoroscopic images of patient anatomy in a hospital or medical clinics.

ZEN-2090 Turbo, C-arm mobile is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films. ZEN-2090 Turbo is consisting of the X-ray tube, X-ray tube assembly, X-ray controller, XTV Camera and some accessories.

OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, and stone localization.

OSCAR Prime and OSCAR Classic are classified according to the option of image acquisition parts. Flat panel detector is OSCAR Prime, and Image intensifier is OSCAR Classic. And they are called OSCAR as the brand name. OSCAR is consist of X-ray Tube, X-ray tube assembly, x-ray controller, image receptor and some accessories. There is no wireless function in this device. The OSCAR, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.

PORT-X IV is a portable X-ray system to be used by trained dental technicians as a mobile, extra oral x-ray source for producing diagnostic x-ray images using intra oral image receptors. It is intended for both adult and pediativ subjects.

The portable X-Ray system, PORT-X IV, is intended to be used by trained dentists and dental technicians as an extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is the X-ray equipment and uses it to diagnose the patient to acquire images. It also includes accessories, which are battery, recharging unit and hand switch.

PAPAYA 3D Plus is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, indicated for use in: - (i) producing panoramic X-ray images of the maxillofacial area, for diagnostic examination of dentition (teeth), jaws and oral structures; and - (ii) producing radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with the cephalometric arm; - (iii) producing tomographic images of the oral and maxillofacial structure, for diagnostic examination of dentition(teeth), jaws ,oral structures and some cranial bones if equipped with CBCT option. The system accomplishes tomographic exam by acquiring a 360-degree rotational X-ray sequence of images and reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two dimensional images and three-dimensional renderings.

PAPAYA 3D Plus is a diagnostic imaging system which consists of multiple image acquisition modes; panorama, cephalometric, and computed tomography. PAPAYA 3D Plus designed for dental radiography of the oral and craniofacial anatomy such as teeth, jaws and oral structures. PAPAYA 3D Plus is equipped with extra-oral flat panel x-ray detectors which is based on CMOS digital X-ray detector and has CT, panoramic and cephalometric radiography with an extra-oral x-ray tube. CMOS Flat panel detectors are used to capture scanned image for obtaining diagnostic information for craniofacial surgery or other treatments. And it also provides 3D diagnostic images of the anatomic structures by acquiring 360°rotational image sequences of oral and craniofacial area.