The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.
Intended Use
The Aurora system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, combined with Computed Tomography for attenuation correction and anatomical localization, applicable to head, whole body, cardiac and vascular X-ray CT.
Technology
Aurora combines a dual NaI-based detector NM system for planar and SPECT imaging (with a new real-time time activity curve option) and a CT system based on the commercially available GE Revolution Ascend 64-slice CT system, with an extended SPECT-CT scan range and standard conformance to IEC 60601-1 and related standards.
Performance
Aurora underwent extensive design control and verification testing including risk analysis, design reviews, unit and integration testing, performance and safety testing, and simulated use validation. Additional bench testing evaluated lesion detectability, dose reduction, quantitation accuracy, low dose CT performance, and workflow. Clinical images were not included due to equivalency with predicate devices. Aurora complies with IEC 60601-1 standards and NEMA NU-1 performance.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/21/2024
1 month - 2
FDA Approval
1/17/2025
Other devices from GE Medical Systems Israel, Functional Imaging
- Clarify DL2025 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.