Revolution Vibe

The Revolution Vibe is a multi-slice CT scanning system designed for head, whole body, cardiac, and vascular X-ray imaging. It produces cross-sectional images by computer reconstruction of X-ray transmission data using various scan techniques (axial, cine, helical, cardiac, gated), with optional spectral imaging capability and low-dose lung cancer screening functionality.

The primary change versus the predicate is a modified detector design optimized for cardiac imaging, supporting both 256 x 0.625 mm rows (16 cm Z-coverage in 32 cm field of view) and 64 x 0.625 mm rows (4 cm Z-coverage in 50 cm field of view). It retains the same 80 cm bore, gantry rotation speeds (0.23–1.0 seconds), Gemstone scintillator material, reconstruction algorithms (FBP, ASIR-V, DLIR, MaxFOV 2), and advanced features including deep learning reconstruction, spectral imaging via ultrafast kV switching, ECG-less cardiac imaging, and Auto ROI with AI integration.

AAMI/ANSI ES 60601-1, IEC 60601-1 Ed. 3.2 and associated collateral and particular standards, 21 CFR Subchapter J, NEMA standards XR 25, XR 26, and XR 28, and IEC 61223-3-5 ed.2 for dose and image quality specifications.

The Revolution Vibe employs identical fundamental operating principles and core technologies as the predicate Revolution Apex Elite, with changes limited to detector geometry and corresponding software modifications that do not alter control mechanism, energy type, intended use, or patient population. Non-clinical bench testing demonstrated equivalent performance; clinical reader study of 30 cardiac exams by three experienced radiologists confirmed diagnostic utility and safety; Auto ROI testing on 1341 clinical images exceeded acceptance criteria. These modifications address a specific clinical need (cardiac imaging optimization) within the established predicate framework without raising different safety or effectiveness questions.