(67 days)
The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The Bel-Cypher dental panoramic and cephalometric X-ray system is indicated for use as a generator of radiographic images of the dento-maxilofacial region and is intended for dental examination and diagnosis of diseases of the teeth, jaw, and oral structures.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) Premarket Notification for a dental X-ray system, primarily focusing on its substantial equivalence to previously marketed devices and regulatory information.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or ground truth establishment for any test sets.
- Information on expert involvement, adjudication methods, or MRMC studies.
- Data on standalone algorithm performance.
- Sample size or ground truth establishment for a training set.
The information provided is mostly administrative and regulatory, establishing the device's classification, intended use, and substantial equivalence to a predicate device (ANA-BEL) by Takara Belmont.
§ 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.