Definium Tempo Select

The Definium Tempo Select is a stationary digital radiographic X-ray system designed to generate diagnostic images of the skull, spine, chest, abdomen, extremities, and other body parts in patients of all ages. It includes an overhead tube suspension, elevating table, motorized wall stand, wireless detectors, and image processing software, with optional image pasting to stitch sequential radiographs together.

Key differences from the predicate Discovery XR656 HD include: removal of VolumeRAD tomography option; use of a single 17×17 detector instead of three detector sizes; updated high voltage generator with different supplier; upgraded tube head console from 6-inch to 12-inch display; reduced OTS motion control from 5-axis to 4-axis with tube auto-angulation added; improved image pasting with individual exposure parameter adjustment; enhanced camera workflow with patient size suggestions and detector outlines; and AI-enhanced tissue equalization algorithm replacing pre-tuned parameters.

Not stated in this summary.

The device maintains identical or equivalent intended use, indications, user population, software architecture, X-ray tube, collimator, DAP calculation, DICOM compatibility, and detector loading specifications as the predicate. While component upgrades and feature enhancements are present (AI tissue equalization, enhanced camera workflow, improved image pasting), these represent evolutionary improvements to existing functions rather than new safety or effectiveness risks. Verification and validation testing across anatomical phantoms and clinical images confirmed safety and effectiveness were not adversely affected. The removal of VolumeRAD and consolidation to a single detector size actually narrows the scope of use, reducing rather than expanding potential risks.