Nanox.ARC X
Nano-x Imaging Ltd.The Nanox.ARC X is a stationary digital tomosynthesis X-ray system designed to create detailed tomographic images of various body parts, including musculoskeletal, pulmonary, abdominal, and sinus regions. It complements traditional X-ray imaging by producing slice images that reduce the overlap of structures, enhancing diagnostic clarity. The system operates multiple low-dose X-ray sources sequentially and reconstructs images either locally or via a secure cloud, aiding clinicians in more precise diagnosis and patient care in adult patients under professional healthcare settings.
Intended Use
Nanox.ARC X 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
The Nanox.ARC X uses a multisource, tiltable arc gantry with five identical cold-cathode X-ray tubes activated sequentially to acquire low-dose images from multiple angles during a single tomographic sweep. Images are reconstructed automatically either locally or through the secured Nanox.CLOUD service using digital tomosynthesis technology.
Performance
The device underwent extensive non-clinical bench testing, including system electrical qualification, performance tests, longevity and reliability assessments, motion control, image quality validation, phantom validation, human factors summary, software verification and validation, and more. No clinical tests were performed. The device was found to be as safe and effective as its predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/20/2025
27 days - 2
FDA Approval
4/16/2025
Other devices from Nano-x Imaging Ltd.
- Nanox.ARC2024 • 510K
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