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The Adora DRFi is a direct radiography and radioscopy, universal and permanently installed diagnostic X-ray system with a flat panel detector, which allows the acquisition of a wide range of Xray examinations. It is intended for use in generating diagnostic and radioscopic images of human anatomy. The Adora DRFi X-rav system is intended for use by trained and qualified personnel at the entire body of both adult and pediatric patients, and exposures may be acquired with the patient in supine, standing or sitting positions as well as with the patient in e.g., a wheelchair or on a stretcher. Radiographic procedures can take place with the detector in free position as well as fixed in the docking station: whereas radioscopic procedures may only take place when the detector is fixed in the docking station.

The Adora DRFi is not for mammography examinations.

The Adora DRFi x-ray system is a ceiling suspended universal x-ray system using direct radiography and radioscopy on flat panels for diagnostic purposes. The system can be used for acquisition of a wide range of radiographic and radioscopic x-ray examinations of the whole body, on both adult and pediatric patients. The patients may be lying on the Adora table, in a hospital bed or on a stretcher, using the flat panel's ability to be placed either inside or outside its housing for radiographic examinations. Radioscopic examinations, however, can only be made with the flat panel in the housing suspended in one of the two telescopes. The patients may also be standing on the floor, sitting on a chair or in a wheelchair. Examinations which can be performed on Adora X-ray systems; Radiography for Pelvis Supine, Pelvis Standing, Knee, and Radioscopy for Esophagus, Tube placement, knee.

The positioning of the ceiling suspended X-ray tube and the flat panel relative to the patient and each other are controlled by the operator, either through a joystick or via pre-programmed auto-positions activated by the operator.

The Adora X-ray system is a main powered, permanently installed system for use in hospitals and x-ray clinics and is intended solely for use by healthcare professionals, trained in and qualified for the use of medical xray equipment for diagnostic purposes.

This FDA 510(k) summary for the Adora DRFi X-ray system does not contain the detailed acceptance criteria or a study proving the device meets an acceptance criterion for an AI/ML medical device.

The document describes a conventional X-ray system (Adora DRFi) and compares its technical specifications to a predicate device (Siemens Multitom Rax). The focus is on demonstrating substantial equivalence based on shared indications for use, target population, and comparable technical aspects (detector technology, generator performance, imaging modalities, positioning capabilities, and table specifications).

Therefore, I cannot provide the requested information, particularly regarding AI/ML device performance, acceptance criteria, sample sizes for test/training sets, expert adjudication, or MRMC studies, as these elements are not detailed in the provided text.

The document indicates that the Adora DRFi utilizes the Canon CXDI-RF Wireless B1 with the Canon CXDI imaging software for image acquisition and post processing, previously cleared under K232298. This suggests that any software-related "AI" aspects (if they exist) would have been cleared under a separate submission (K232298) and are not the primary focus of this 510(k) for the Adora DRFi hardware system.

The "Conclusions" section reiterates that the device is substantially equivalent and that "Testing demonstrates that this device will perform in a manner that is as safe and effective or better than the predicate device." However, the details of this testing are not provided in this summary, especially not in a way that aligns with the typical requirements for an AI/ML device study.

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