(38 days)
The Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability that is the subject of this 510(k) is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, oral structure, TM-joints and skull by exposing an X-ray image receptor to ionizing radiation.
The Veraviewepocs Panoramic X-ray Unit is an FDA-cleared extraoral source X-ray unit that it used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation (K#013955). The modified Veraviewepocs covered by this submission simply adds a cephalometric capability to the existing device. In addition to manual settings, the modified Veraviewepocs also has an "auto exposure" feature in the cephalometric mode. Exposure time is automatically adjusted depending on the patient's size, and the device is set at 80 kV and 10mA. A sensor behind the cephalometric cassette measures the amount of x- radiation, and the exposure is terminated once the accumulated x-radiation reaches a certain level.
The provided text describes a 510(k) summary for the J. Morita Manufacturing Corporation's Veraviewepocs Panoramic X-ray Unit with Cephalometric Capability. However, it does not contain specific acceptance criteria or a dedicated study section detailing performance metrics, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic performance.
The document focuses on:
- Substantial Equivalence: Comparing the modified Veraviewepocs (with cephalometric capability) to predicate devices (Instrumentarium Corporation Imaging Division's Orthopantomograph OP100 and ORTHOCEPH OC 100).
- Technological Characteristics: Describing the added cephalometric feature and its "auto exposure" functionality.
- Safety and Compliance: Stating that the device complies with electrical safety standards (UL2601-1, IEC 60601-1), software validation, and biocompatibility for materials.
- Intended Use: Broadly for dental radiographic examination and diagnosis.
Therefore, I cannot populate the requested tables and information regarding acceptance criteria, device performance, study details, or ground truth as this information is not present in the provided text. The document primarily attests to regulatory compliance and substantial equivalence rather than a detailed clinical performance study.
§ 872.1830 Cephalometer.
(a)
Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.(b)
Classification. Class II.