Nanox.ARC
Nano-x Imaging Ltd.The Nanox.ARC is a stationary, stand-alone digital tomosynthesis X-ray system designed to produce tomographic images of various body regions like musculoskeletal system, lungs, abdomen, and paranasal sinuses. It aids clinicians by providing 3D-like images synthesized from multiple low-dose X-ray images taken during a single sweep, helping reduce overlap of structures and improving diagnostic accuracy. The system is intended for use by trained radiologists and technologists in hospitals and imaging centers for adult patients.
Intended Use
Nanox.ARC is a stationary X-ray system intended to produce tomographic images for general use including human musculoskeletal system, pulmonary, intra-abdominal, and paranasal sinus indications, adjunctive to conventional radiography, on adult patients.
Technology
Nanox.ARC includes a stationary, floor-mounted, stand-alone digital tomosynthesis system with a multisource, tiltable arc gantry having five identical X-ray tubes operated sequentially. It acquires multiple low-dose images from different angles during a single sweep, with a motorized patient table, and reconstructs tomographic slices automatically. The system includes a flat panel scintillator-photodetector, with image reconstruction and DICOM services available locally or via secured cloud.
Performance
Performance testing included clinical sample data evaluation, chest phantom validation, weight considerations for performance, and system performance tests. Results demonstrate that Nanox.ARC produces diagnostic-quality tomographic images for the expanded indications of use with safety and effectiveness similar to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/13/2024
3 months - 2
FDA Approval
12/4/2024
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