Aurora

The Aurora is a hybrid SPECT-CT imaging system combining a nuclear medicine (NM) scanner with a 64-slice CT system for detecting radioisotope tracer uptake and producing cross-sectional anatomical images. It is intended for general nuclear medicine procedures, CT-based attenuation correction of SPECT images, and standalone head, whole body, cardiac, and vascular CT applications for diagnosing cardiovascular disease, neurological disorders, and cancer.

Aurora replaces the predicate's 16-slice Optima CT540 CT subsystem with the more advanced 64-slice Revolution Ascend CT system. The NM subsystem remains unchanged from the predicate Discovery NM/CT 670. Aurora introduces a new 'Real-time Time Activity Curve' software option for live monitoring of radiopharmaceutical uptake during planar dynamic imaging and extends the SPECT-CT scan range from 160 cm to 185 cm.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-3 (radiation safety), IEC 60601-2-44 (SPECT/CT particular standard), and NEMA NU-1 (nuclear medicine performance standards).

The NM imaging component is identical to the predicate, while the CT component is a commercially available cleared device (Revolution Ascend K213938) that has already undergone FDA review. Design control testing identified no new hazards or unexpected results. The modifications do not change the intended use, control mechanisms, operating principle, or energy type. The new software feature and extended scan range represent incremental enhancements that do not introduce new safety or effectiveness questions, supported by engineering bench testing demonstrating equivalent performance.