(132 days)
NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine 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 device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 derree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine 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 device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
NewTom 5G is especially designed for:
- dento-maxillo-facial complex imaging;
- teeth, mandible and jaw imaging for implant planning;
- temporal-mandibular joint (TMJ) imaging;
- ear, nose and throat (ENT) analysis;
- sections of upper cervical-spine imaging;
NewTom VGi and NewTom 5G are cone beam computed tomography x-ray imaging systems that acquire a 360 degree rotational sequences of the head. The devices reconstruct a three dimensional matrix of the examined volume and produce two dimensional views of this volume, displaying both two and three dimensional images.
Based on the provided documents for K130442, which describe the NewTom VGi and NewTom 5G computed tomography x-ray systems, the information requested to describe acceptance criteria and associated studies is not available.
These documents are a 510(k) clearance letter and Indications for Use statements. They specify the regulatory clearance of the devices for diagnostic support in various anatomical regions of the head and neck. They do not contain clinical study data, performance metrics, acceptance criteria, sample sizes, or details about ground truth establishment.
To answer your request, detailed performance data from the 510(k) submission itself would be needed, which is not part of these publicly available summary documents.
Therefore, I cannot provide the requested table and study details. If you have access to the full 510(k) submission, that would be the source for this information.
§ 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.