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x-mind dc (and Owandy-RX DC under trademark Owandy Radiology) is an X-ray unit, in particular extraoral source of X-rays, intended for intra-oral radiographic exams for diagnostic purposes related to anatomy of teeth and adjacent oral structures both on adult and pediatric patients, using specific x-ray detectors (chemical films, phosphor plates or digital xray sensors) that are not part of the device.

The device is operated and used by dentists, radiologists and other legally qualified health care professionals.

x-mind dc consists of the following parts:

• 1 X-ray control unit (timer)
• 2 Wall plate and horizontal bracket
• 3 Pantograph type arm (scissor arm)
• 4 X-ray source assembly (tubehead)
• 5 Collimator cone (Beam Limiting Device)

The timer is the control panel used to manage the exposure settings and to safely use the tubehead. It allows easy and clear selection, with the help of clear and visible signals, of the exposure settings, perform personal settings and display alarms of the device in case of incorrect operation or eventual failures.

The horizontal bracket it is available in 3 different lengths and represents the support for the scissor arm. The pantograph arm, being adjustable in height and depth, allows the precise positioning of the tubehead. The tubehead of the device contains the X-ray tube, the high voltage board and the high frequency generator. It is the component of the device which emits the X-rays.

The collimator cone represents the part of the device in contact with the patient and it allows the correct focal spot to skin distance, ensures the dimension, direction and centering of the X-ray beam.

x-mind dc can be used with conventional chemical films (D, E, F speed films), phosphor plates (PSP), RVG digital detectors (CCD or CMOS).

The provided text outlines the 510(k) summary for the x-mind dc (and Owandy-RX DC) device, which is an extraoral source X-ray system intended for intra-oral radiographic exams. The core of the summary demonstrates substantial equivalence to a predicate device, Endograph DC (K130109), and a reference device, PHOT-X II, MODEL 303 (K042260).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for the device in the sense of performance metrics like sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, it details the device's technical specifications and compliance with various international and national standards and regulations. The "acceptance criteria" here are implicitly the successful adherence to these standards, demonstrating safety and essential performance comparable to the predicate device.

To frame this in the requested format, we can list key technical specifications and their comparison to the predicate/reference devices, which serve as the "performance" verification. The ultimate "acceptance criterion" is the determination of substantial equivalence by the FDA.

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