(166 days)
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.
The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires of the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw, temporo-mandibularjoint (TMJ), other areas of human skull and neck with sections of upper cervical spine, and lower extremities for use in diagnostic support. The device accomplishes this task by reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of this volume, displaying both two and three dimensional images.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "NewTom 5G" device. The document is primarily a 510(k) clearance letter from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices, and outlining regulatory requirements. It specifies the "Indications for Use" for the device but does not detail any performance studies, data provenance, expert qualifications, or ground truth methodologies.
§ 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.