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Hasla is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product (Dental CBCT X-ray System, Model: Hasla) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

The Dental Cone Beam Computed Tomography System is intended to be used by medical institutions for X-ray image diagnosis on oral and maxillofacial areas through X-ray Cone Beam Computed Tomography (CBCT).

The system consists of X-ray tube assemblies, collimators, flat panel detector, control devices (the touch screen, the control panel, the console panel and the exposure switch), auxiliary positioning devices(the lifting seat and the chin rest) and U-shape gantry (the X-ray tube assembly support, the base and the Detector Support), and workstation. The system is an open design that allows patients to sit upright during a procedure. An electric powered seat is built into the scanner for proper patient positioning. The system has 2 configurations: the Configuration 1 has two X-ray tube assemblies(X-ray tube assembly A and X-ray tube assembly B) and two collimators(A and B), the Configuration 2 only has X-ray tube assembly A and collimator A. The proposed device is a CBCT dental system utilizes X-ray to obtain cross-sectional images of patient's oral and maxillofacial areas. The image software can reconstruct data and clearly display the 3D anatomical structure of the oral and maxillofacial areas, and achieve the multi-slice at any level, accurate measurement, contour plots and so on in the workstation software, greatly facilitating the clinical application of stomatology. The Lifting Seat moves up and down via buttons on the system Control Panel allowing positioning and adjustment of patients at different heights; the Touch Screen facilitates the adjustment of projection parameters and the control of actions of the device; the Gating and the shielding door are the safety interlock of the X-ray beam exposure to prevent the dose leakage caused by abnormal operation; the Exposure Switch controls the exposure output of the whole machine in real time during the scanning process. There are four FOV sizes; 20cm x 18cm high resolution is for diagnostic imaging of maxillary region, mandibular region, TMJ region and other craniofacial region, and it is only available for configuration 1; 17cm x 10.5cm high resolution , 8cm x8cm Super Resolution and 4cm x4cm Super Resolution are for diagnostic imaging of maxillary region and mandibular region. Under High Resolution mode, patients will receive lower radiation dose compared to Super Resolution. Dose radiation for each mode is different for pediatric and adult patients.

RCT600 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus and TMJ structure for adult and pediatric patients. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified heath care professionals.

RCT600 provides 3D computed tomography for scanning hard tissues such as bone and teeth. By rotating the C-arm, which houses a high-voltage generator, an X-ray tube and a detector on each end, CBCT images of dental maxillofacial structures are obtained by recombining data scanned from the same level at different angles. Functionalities include panoramic image scanning for obtaining images of whole teeth, and a cephalometric option for obtaining cephalometric images.

Green X 12 SE (Model : PHT-40CHS) is intended to produce panoramic, cephalometric, or 3D digital x-ray images. It provides diagnostic details of the dento-maxillofacial, sinus, and TMJ for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

Green X 12 SE (Model : PHT-40CHS) is an advanced 4-in-1 digital X-ray imaging system that incorporates PANO, CEPH(optional), CBCT and MODEL Scan imaging capabilities into a single system. Green X 12 SE (Model : PHT-40CHS), a digital radiographic imaging system, acquires and processes multi-FOV diagnostic images for dentists. Designed explicitly for dental radiography. Green X 12 SE (Model : PHT-40CHS) is a complete digital X-ray system equipped with imaging viewers, an X-ray generator and a dedicated SSXI detector. The digital CBCT system is based on a CMOS digital X-ray detector. The CMOS CT detector is used to capture 3D radiographic images of the head, neck, oral surgery, implant and orthodontic treatment. Green X 12 SE (Model : PHT-40CHS) can also acquire 2D diagnostic image data in conventional PANO and CEPH modes.

Green X 21 (Model: PHT-90CHO) is intended to produce panoramic, cephalometric, or 3D digital Xray images. It provides diagnostic details of the dento-maxillofacial, sinus, TMJ, and ENT for adult and pediatric patients. The system also utilizes carpal images for orthodontic treatment. The device is to be operated by healthcare professionals.

Green X 21 (Model : PHT-90CHO) is an advanced 6-in-1 digital X-ray system specifically designed for 2D and 3D dental radiography. This system features six imaging modalities: PANO, CEPH (optional), DENTAL CT, ENT CT, MODEL, and FACE SCAN, all integrated into a single unit. Green X 21's imaging system is based on digital TFT detectors, accompanied by imaging viewers and an X-ray generator. The materials, safety characteristics, X-ray source, indications for use and image reconstruction/MAR(Metal Artifact Reduction) algorithm of the subject device are same as the predicate device (PHT-75CHS (K210329)). The subject device differs from the predicate device in the following ways: It is equipped with new X-ray detectors for CT/PANO and CEPH modification results in a different maximum FOV provided in a single scan for CT mode compared to the predicate device. For CEPH modality, the subject device utilizes a one- shot imaging capture method. Additionally, the subject device includes new modalities such as ENT CT and FACE SCAN with a face scanner, along with new software functions, including Auto Pano, Smart Focus, and Scout.

FinScan F350 is CBCT, panoramic and cephalometric x-ray imaging system. The device is intended to radiographic examination of the dento-maxillofacial and TMJ structure for diagnostic support for adult and pediatric patients. Cephalometric image also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or other legally qualified health care professionals.

Dental Cone-beam Computed Tomography (model: FinScan F350) uses cone-beam computed tomography (CBCT) technology through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dento-maxillofacial and TMJ structure to provides diagnostic details for dental clinics and dental hospitals. This product mainly consists of column, rotating unit, tube head assembly, CBCT/panoramic detector, cephalometric detector, the workstation and image processing software.

ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that is intended to be used for imaging of adult and pediatric patients. The device can be configured to take panoramic, cephalometric or 3D images of cranio-maxillofacial complex including the ear, nose and throat (ENT) and airway regions, and cervical spine. The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals.

ORTHOPANTOMOGRAPH™ OP 3D LX is a digital panoramic, cephalometric and cone beam computed tomography (CBCT) x-ray device. OP 3D LX is used for imaging of the craniomaxillofacial complex and neck areas including the ear, nose and throat (ENT) for diagnostic and treatment planning purposes.

T2 PLUS is digital X-Ray imaging equipment for dental professionals that converts X-Ray signals into digital signals to acquire 2D images and reconstruct them into 3D images, using Panoramic (PANO), Cephalometric (CEPH), and Computed Tomography (CT) technology for the diagnosis of the anatomical structure of the oral and maxillofacial area. T2-CS-P provides all three modes, whereas T2-C-P provides the first two modes and excludes the CEPH mode. The devices are operated and used by physicians, dentist and X-Ray technicians. Use is contraindicated for patients with a head circumference of less than 48 cm or those aged 2 years or younger.

T2 PLUS is a digital X-ray CT, panoramic, and Cephalo imaging system device composed of X-ray generator, X-ray controller, X-ray supporter, image processing unit (sensor), PC, and software. The apparatus attached to the equipment column is a structure that can be rotated 360 by the system control unit. This system control unit actuates the motor control, X-ray generator, and image processing unit (sensor). The height controlling unit controls the column and adjusts the height of the equipment. The X-ray generator and image processing unit (sensor) are attached to the rotating apparatus. When the rotating apparatus starts the rotation, X-ray is irradiated from the Xray generator (generating unit). This X-ray irradiation penetrates the subject and reaches the image processing unit (sensor), and then is converted into electric signals to secure imagery information. Inside the imaging section of the image processing unit (sensor), real time X-ray input is converted into electric signals and consecutively combined, resulting in imagery information. The combined panoramic imagery information is then sent to the PC and saved in patient management software.

KP-View 3D is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

The product ( Dental Cone-beam Computed Tomography, Model: KP-View 3D) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube, Collimator), Image receptor and Image processing system (including Computer, Monitor, and Software workstation).

Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients. This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.

( Product Name: Dental Cone-beam Computed Tomography, The product Model:iDT901X1) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube,Collimator), Image receptor and Image processing system (including Computer, Monitor, Software workstation).