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The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral images of a patient's mouth while reducing the necessary x-ray dosage.

The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. The images are displayed on a computer workstation. The modified device uses wireless IEEE 802.11 b/g protocol for image data transfer and control signal transfer to and from the Power and Transceiver (PAT) and the host computer. A rechargeable battery power source is also included in the PAT. A Counter Top Dock (CTD) has been added to this system. The CTD is a support device that provides charging power to the PAT and is used to provide a temporary wired connection, via USB, from the host computer to the PAT to allow initial configuration to the host wireless network.

The Computed Oral Radiology System is intended for intra-oral x-ray examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-ray dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K072134. The Computed Oral Radiography System is indicated for patients undergoing an intra-oral dental X-ray examination. It produces instant digital intra-oral X-ray images of a patient's mouth.

The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new scintillation material differs from the predicate in that in that it affords higher resolution and lower noise. Direct triggering via an x-ray tube continues to be supported as was cleared in K072134 and K041385. The modification offers an improvement in image quality.

The Computed Oral Radiology System is intended for intra-oral x-rav examinations and indicated for dental patients. It produces instant, digital, intraoral x-ray images of a patient's mouth while reducing the necessary x-rav dosage. This device modification in no way alters the indications for use of this machine beyond what was most recently cleared in K041385.

The device and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. A new control mechanism differs from the predicate in that image acquisition is initiated via a new hardware trigger residing on the CMOS ASIC. Direct triggering via an x-ray tube continues to be supported as was cleared in K041385. The modification offers an improvement in system-level support. The modification in no way alters the fundamental technology nor intended use.

The Ceph Model 4900 is indicated for individuals requiring extra-oral dental examinations.

The Ceph Model 4900 is intended to replace x-ray film in the acquisition of diagnostic cephalometric x-ray images of the skull as are commonly used in orthodontics to measure skeletal changes and monitor oral growth and development. The device works with a cleared x-ray device, along with a specialized collimator and positioning elements that are bundled together and sold as the PanCeph system.

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film. The new control mechanism differs from the predicate in that image acquisition may additionally be triggered through a hardwire to an x-ray tube. This modification allows for a quicker x-ray response time and may improve ergonomics as it eliminates the need for a standalone remote module. The existing firmware has been altered to support the modified and additional hardware. The new remote module may be housed within a specified x-ray source. The modification in no way effects the fundamental technology governing image acquisition.

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.

The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.

The device is a small digital imaging receptor that may be used in place of dental x-ray film. The proposed device modification alters the method of communication between the sensor and computer from a wired to wireless interface, introducing a radio frequency transmitter. The wireless sensor is powered via a battery. Image acquisition is mediated through hardware rather than software components. The sensor encapsulation material has been modified from aluminum to a thermoplastic resin. The existing firmware has been altered to support the modified and additional hardware, with firmware installed on both the remote module and the sensor. The firmware on the sensor facilitates unidirectional communication of image and sensor status data to the remote module.

The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.

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The accuDEXA is a dual-energy x-ray device indicated for use in estimating the bone density of the middle finger of the non-dominant hand (BMD). This BMD value is a relative indicator of bone density elsewhere in the body. accuDEXA BMD estimates can be used as an aid to the physician in determining fracture risk.

The accuDEXA device is a Dual Energy X-Ray Absorptiometer (DEXA) device. The device is intended to estimate bone mineral density in the middle finger of the non-dominant hand. By changing the high voltage on the X-ray tube, two energies are produced. Each of the two settings produces an image of the finger and each image is analyzed using various algorithms to produce a value of bone mineral density (BMD) and bone mineral content (BMC). These values are compared with a normative database, yielding a t-score and a z-score. The t-score is the number of standard deviations that the patient is above or below the mean of a reference sample of young healthy individuals. The z-score is the number of standard deviations that the patient is above or below the mean of a reference sample of individuals of the same age as the patient.