ExamVue Apex

The ExamVue Apex is a digital X-ray detector system consisting of three flat panel detector models (EVA 10W, EVA 14W, EVA 17W) paired with ExamVue Duo acquisition software. It captures digital X-ray images by converting X-rays to electronic signals via an amorphous silicon collector and cesium iodide scintillator, eliminating the need for film. It is indicated for general and specialist radiology including podiatry and orthopedics, and mobile X-ray systems, but not mammography.

Both devices use amorphous silicon detectors with cesium iodide scintillators and perform the same core functions of image acquisition, transfer, and processing in DICOM format on Windows. The ExamVue Apex differs in detector resolution (99 μm pixel pitch versus 143/140/143 μm), substrate electronics materials, and uses newer Thales hardware instead of Toshiba. The software (ExamVue Duo, K213057) is the direct successor to the predicate's ExamVueDR software, with additional measurement and management tools that do not impact core functionality.

Testing followed IEC 62304 (software lifecycle), IEC 62366-1 (usability engineering), IEC 60601-1-2 through 1-8 and 2-54 (electrical safety and essential performance for X-ray equipment), IEC 60529 (enclosure protection), IEC 61000 series (electromagnetic compatibility), ISO 10993 (biocompatibility), and IEC 60950-1 (IT equipment safety). Bench testing compared resolution, sensitivity, dynamic range, and software function equivalence.

Both devices share identical intended use (general and specialist radiology, mobile X-ray), employ the same detector technology (amorphous silicon plus CsI scintillator), provide equivalent image acquisition and processing workflows, use DICOM 3.0, and interface with multiple hardware models on Windows. The ExamVue Apex's improved resolution (finer pixel pitch) and refined substrate represent hardware evolution, not technological change. The newer software is the direct successor performing identical core functions with additional non-critical features (measurement, management tools) already present in prior 510(k) approvals. Clinical evaluation by ABR-certified radiologist confirmed equivalent or superior image quality, and no new scientific principles are introduced.