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The O-Rad Radiographic System is indicated for use in obtaining diagnostic quality radiographic images to aid the physician with diagnosis. The system can be used to perform radiographic imaging of various portions of the human body, including the skull, spinal column, extremities, chest, abdomen and other body parts. The Q-Rad System is not indicated for use in mammography.

The Q-Rad Radiographic System is general-purpose radiographic (X-ray) system used for acquiring radiographic images of various portions of the human body. The Q-Rad System consists of a combination of several components including various models of Xray generators and control panels or workstation computers, various models of patient support tables with integrated image receptor(s), wall-mounted image receptor/detector units for upright imaging, tube supports (ceiling-suspended or floor-mounted), and an Xray source and collimator (beam-limiting device). The Q-Rad System is available with conventional analog (film cassette), digital radiography (DR) and computed radiography (CR) receptors: systems equipped with DR or CR modalities can also be configured to include a workstation computer that is fully integrated with the X-ray generator to allow communication of information such as image exposure factors directly from a connected RIS/PACS (radiology information system / picture archiving and communications system). The currently marketed Q-Rad System requires manual motion control for 3axis alignment of the X-ray source (tube) and the image receptor/detector located in the patient table or wall stand. This Special 510(k): Device Modification is for the introduction of optional Auto-Tracker functionality to improve the ergonomics of the user - device interface of the currently marketed Q-Rad Radiographic System. The Auto-Tracker function provides optional automated, motorized vertical tracking of the X-ray tube to the image receptor. Q-Rad Systems with the Auto-Tracker option will have a motor added to the X-ray tube support, and position sensors incorporated into the image receptors/detectors located in the patient table and/or in the wall-mounted image receptor unit. The motor and image receptors are linked via a CANbus communication interface, which allows the X-ray tube to automatically align with the vertical position of the image receptor, which is still manually positioned by the operator. The automated tracking feature applies only to vertical positioning; the operator must still manually align the X-ray tube with the image receptor in the X- and Y-axes (longitudinal and lateral/transverse positioning). The addition of a motor to the X-ray tube support also enabled the addition of optional motorized vertical positioning of the X-ray tube using a "tube-up" or "tube-down" switch; this option is independent of the auto-tracking capability, and is offered as a convenience to the operator as an alternative to the fully manual tube up/down positioning on standard (non-Auto-Tracker) Q-Rad Systems. The standard O-Rad System without Auto-Tracker option will still be available, and the operator will have the option of disabling the Auto-Tracker function at any time if fully manual tube positioning is preferred.