Search Results

Orthopantomograph® OP200 (film unit) and OP200 D (digital unit) devices are intended to be used for producing X-ray radiographs of dentition, TM-joints and other oral structures. The units are capable of taking panoramic, TM-joint and maxillary sinus radiographs from patients. When the units are equipped with cephalometric option Orthoceph® OC200 (film unit) or OC200 D (digital unit) units can be used for cephalometric radiography and examinations related thereto. OP200 or OC200 units can also be equipped with Ortho Trans (OT) option, which is capable of taking both cross and longitudinal slices of region of interest. Ortho Trans uses linear tomography imaging principle.

Panoramic X-ray devices Orthopantomograph® OP200, OP200 D and cephalometric options Orthoceph® OC200, OC200 D are the next generation in the Orthopantomograph® and Orthoceph® family. In the case of OP200 and OC200 devices, the image is captured to the film whilst OP200 D and OC200 D offer digital imaging. The units include patented V-shaped X-ray beam that adapts to the bone density and structure of the human anatomy. In the OP200 D and OC200 D the imaging geometry remains the same as in film-based imaging (OP200, OC200), thereby enabling comparison to earlier film-based studies. The patient positioning is easy and accurate thanks to motorized movements and three light lines for correct positioning of the patient's head. The patient's midsagittal view can be seen in a panoramic mirror and the electrically locked rigid forehead support is used to stabilize the head. Patient positioning can be performed on the left or right side. When OP200 or OC200 units are equipped with CR option they have bigger 24x30cm cassette holder in panoramic side. Normal cassette holder size is 15x30cm. With this bigger 24x30cm cassette holder CR imaging plates can be used. Optional Ortho ID film marking system can be used to store exposure parameters, patient and clinic information to films. Ortho ID is connected to OP200 or OC200 film units. Equipments are designed to be field upgradeable. This means that for example basic OP200 film unit can be field upgraded to OC200 (cephalometric imaging) or OP200 D digital or OC200 D digital. All different options like OT, CR, etc. can be field upgraded afterwards.

This 510(k) premarket notification for the Orthopantomograph® OP200, OP200D and Orthoceph® OC200, OC200D devices is for traditional X-ray equipment and does not contain information typically found in submissions for AI/ML-driven medical devices, such as performance criteria based on AI algorithm outputs, clinical study data comparing AI to human performance, or detailed data provenance for AI model training/testing.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML device evaluations.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, composition, and function for conventional dental panoramic and cephalometric x-ray imaging.

Ask a specific question about this device