(85 days)
The Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is to be used as an extraoral source of x-rays for imaging of the dento-maxilofacial area.
The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is an extraoral source of x-rays for imaging of the dento-maxilofacial area.
The Dentsply/Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System is comprised of the following main components:
- High frequency inverter which supplies a true DC output and accurate technique factors
- A microprocessor controlled user-friendly electronic control
- A motorized column to be fixed to the wall .
- Counter balanced overhead carriage with controls for patient positioning, setting and . control of technique factors and radiographic projection geometry
- Cassette drive system with flat cassette for 15x30 cm film .
- X-ray tubehead, with DC power supply via electronic converter .
- Remote control box and handswitch .
- Optional cephalometric arm and head positioner ●
- Optional utilities for transverse scanography of the jaw ("Transcan®") .
During a panoramic exposure, the x-ray tube and cassette holder moves around the patient's head. The beam from the x-ray tube is collimated by a slit diaphragm. The flat film cassette passes behind a secondary collimator which blocks the radiation scattered from the patient. Patient positioning is by means of a bite guide and a headrest. During exposure, the patient, remains still while the motorized components rotate.
All movements for the panoramic radiographic projection are performed by four independent motors, which are microprocessor controlled.
The provided text is a 510(k) Summary Statement for the Gendex Orthoralix 9200 Panoramic and Cephalometric Dental X-Ray System. This document describes a traditional medical device (an X-ray system), not an AI/ML-enabled device. Therefore, the concept of "acceptance criteria" for an AI algorithm's performance, as well as the specific types of studies (MRMC, standalone performance, ground truth establishment, training set details) requested in the prompt, are not applicable to this submission.
The "Safety and Effectiveness Information" section outlines how the device demonstrates safety and effectiveness, which are standard for traditional medical devices:
- Performance testing to meet product specifications: This refers to the engineering and design validation of the hardware and software components of the X-ray system itself, not the performance of an AI algorithm on clinical data.
- Software testing to validate software design / performance: This pertains to the embedded software controlling the X-ray machine's operations, not an AI for image analysis or diagnosis.
- Effective clinical image exposures: This implies that the device produces radiographs of sufficient quality for clinical interpretation, which is a functional requirement of an X-ray system.
- Hazard analysis including risk level and solution: Standard risk management for medical device manufacturing.
- Same indications for use as predicate devices: Demonstrating substantial equivalence to existing devices with established safety and effectiveness.
Since the prompt's questions are tailored for AI/ML device evaluations, and this document describes a traditional X-ray system, it's impossible to extract the requested information.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.