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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:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes, data provenance, or ground truth establishment for any test sets.
3. Information on expert involvement, adjudication methods, or MRMC studies.
4. Data on standalone algorithm performance.
5. 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.

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