(105 days)
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 manufactured by PaloDEx Group Oy is a panoramic, cephalometric and cone beam CT (CBCT) x-ray device for 2D and 3D imaging of patient's cranio-maxillofacial complex. It can be used to capture 2D and 3D x-ray images from pediatric and adult patients. The Primary Predicate Device ORTHOPANTOMOGRAPH™ OP 3D has already been cleared for panoramic and cone beam CT usage (K180947).
The ORTHOPANTOMOGRAPH™ OP 3D LX is an X-ray device that can be configured to take panoramic, cephalometric or 3D images of craniomaxillofacial complex, and neck areas including the ear, nose and throat (ENT). The device can be configured to take carpus images. The device is operated and used by qualified healthcare professionals. The ORTHOPANTOMOGRAPH™ OP 3D LX is intended to be used for imaging of adult and pediatric patients.
The ORTHOPANTOMOGRAPH™ OP 3D LX is part of digital dental workflow providing image data for diagnosis and treatment planning for the healthcare professionals. Xray images reveal the targeted craniofacial anatomy, and condition and the position of anatomical structures inside FOV, such as teeth, mandibular joints, and oral and nasal cavities. This helps dentists to prepare for various dental procedures such as implant placement, orthodontics and dental prosthetics, providing possible early diagnosis, which enables early and less invasive treatment.
The provided text describes the regulatory clearance for the Orthopantomograph™ OP 3D LX. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study that proves the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices (ORTHOPANTOMOGRAPH™ OP 3D (K180947) and Orthopantomograph OP300 (K163423)) for regulatory purposes. It lists various non-clinical bench testing standards related to safety, electromagnetic compatibility, radiation protection, software, usability, biocompatibility, and imaging performance, but does not provide the results of these tests or acceptance thresholds.
The "Clinical Performance Data" section merely states: "A clinical image review was performed in support of establishing substantial equivalence." It does not elaborate on the methodology, results, or specific criteria met.
Therefore, I cannot provide the requested information from the given input. The requested details regarding acceptance criteria, reported performance, sample sizes, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not present in the provided text.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.