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JAZZ Solo sensor is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. It can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images that can be displayed, enhanced, printed, and saved. The JAZZ Solo sensor is a USB-driven digital sensor which is intended to acquire dental intraoral radiography images. The JAZZ Solo sensor shall be healthcare operated on by educated are and competent to perform the acquisition of dental intraoral radiographs. The JAZZ Solo sensor can be used either in combination with the provided JAZZ IMAGING positioners, other universal positioningdevices manufactured to facilitate the positioning and alignmentwith an x-ray beam, or it may also be positioned by hand with the assistance of the patient. The JAZZ Solo sensor can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized. The JAZZ Solo sensor requires a dedicated imaging software package to operate at full potential as a diagnostic imaging device. The imaging software is not included and may need to be purchased separately. Using a JAZZ Solo sensor is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Furthermore, available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis. When using the JAZZ Solo sensor and software as a diagnostic aide, clinical experience and a combination of other diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.

The JAZZ Solo sensor, Model 10-002, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation. The JAZZ Solo sensor design uses advanced ergonomic principles with four beveled corners, a moderate profile and a rounded casing providing enhanced comfort for patients. The JAZZ Solo sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned. The JAZZ Solo sensor has an x-ray imager (CMOS) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ Solo sensor through the standard USB port. Image analysis software is not part of the submission. For the JAZZ Solo sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. The software of the JAZZ Solo sensor being used is unchanged from the predicate JAZZ SOLO Sensor. Firmware for the JAZZ Solo sensor, which controls basic imager function and readout, has been simplified from the predicate JAZZ SOLO Sensor. The JAZZ Solo sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.

The JAZZ SOLO digital sensor is intended to acquire dental intra-oral radiographic images. It can be operated by trained dental professionals for patients receiving intraoral x-ray examinations for diagnostic purposes.

The JAZZ SOLO Digital Sensor, Model 10-001, is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intra-oral radiographs. Digital xray imaging is an aide for diagnosis and should always be confirmed by the doctor using additional procedures and other diagnostic aides for confirmation. The JAZZ SOLO Digial Sensor is positioned in the patient's mouth in the same manner as intra-oral film is positioned. The JAZZ SOLO Digital Sensor has an x-ray imager (CCD) that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to the JAZZ SOLO Digital Sensor through the standard USB port. Image analysis software is not part of the submission. For the Jazz Solo Digital Sensor to be used in a dental practice, an optional image analysis software will be necessary. Only with imaqe analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files and printed out on a suitable printer. The JAZZ SOLO Digital Sensor captures x-ray images suitable for recognition of normal anatomical structures, dental pathologies and abnormal conditions. Inadequate images may result in mis-diagnosis, subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient.