Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253596 FDA 510(k)
- FDA Product Code
- JAK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 is a computed tomography (CT) scanner designed for high-speed imaging. It incorporates advanced technologies, including a CoolNovus X-ray tube and PUREINSIGHT detector, to deliver precise and efficient scans with a gantry rotation speed of 0.24 seconds. This system supports a wide range of clinical applications, including PCCT-inspired protocols, to enhance diagnostic accuracy and workflow efficiency. Its design prioritizes versatility and performance for complex imaging tasks.
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 is intended for use in radiology departments and clinical settings requiring rapid and high-quality CT imaging. It is supplied as a reusable medical device, with specifications and regulatory compliance documented under FDA 510(k) clearance (K253596). The system features a low-profile, open design to accommodate diverse patient needs and workflow demands. Storage and maintenance follow manufacturer guidelines to ensure optimal performance and sterility where applicable.
Frequently asked questions
What clinical applications is the Aquilion ONE (TSX-308A/TSX-306A) V2.0 designed for?
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 is engineered for a broad range of radiology applications, particularly those requiring rapid and high-quality imaging. Its advanced technologies, such as the CoolNovus X-ray tube and PUREINSIGHT detector, support protocols like PCCT-inspired scans, which enhance diagnostic accuracy and streamline workflows. This makes it ideal for complex imaging tasks where speed and precision are critical, such as emergency diagnostics, cardiovascular studies, or detailed anatomical evaluations.
How is the Aquilion ONE (TSX-308A/TSX-306A) V2.0 supplied and is it single-use?
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 is supplied as a reusable medical device, not single-use. It is designed for repeated use in clinical settings, with maintenance and care following manufacturer guidelines to ensure longevity and optimal performance. The system’s durable construction and advanced components, such as the CoolNovus X-ray tube, are intended for sustained operational reliability in radiology departments.
What distinguishes the gantry rotation speed of this CT scanner?
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 features a gantry rotation speed of 0.24 seconds, which is significantly faster than many conventional CT scanners. This rapid rotation enables quicker imaging acquisition, reducing scan times and improving workflow efficiency. The combination of this speed with technologies like the PUREINSIGHT detector ensures high-resolution images are captured swiftly, enhancing diagnostic capabilities for time-sensitive clinical scenarios.
Does the Aquilion ONE (TSX-308A/TSX-306A) V2.0 accommodate diverse patient needs?
Yes, the Aquilion ONE (TSX-308A/TSX-306A) V2.0 is designed with a low-profile, open architecture to better accommodate patients of varying sizes and conditions. This open design reduces claustrophobia for patients and allows for greater flexibility in positioning, making it suitable for a wide range of clinical applications. The system’s versatility ensures it can adapt to diverse patient needs while maintaining high imaging performance.
What regulatory pathway does the Aquilion ONE (TSX-308A/TSX-306A) V2.0 follow?
The Aquilion ONE (TSX-308A/TSX-306A) V2.0 has undergone a traditional 510(k) clearance process through the FDA, with a clearance number of K253596. This pathway confirms that the device is substantially equivalent to a legally marketed predicate device in terms of technology and safety. The system was reviewed by the Radiology (RA) Advisory Committee, ensuring compliance with regulatory standards for CT scanners in clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Aquilion ONE / INSIGHT Edition | Computed Tomography | Canon Medical ..., Aquilion ONE / INSIGHT Edition CT System | Canon Medical Systems USA, Aquilion ONE / INSIGHT Edition (TSX-308A) - kr.medical.canon
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253596 | Class II | Active |
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Manufacturer
- Manufacturer
- Canon Medical Systems Corporation
Sources (1)
- FDA 510(k) K253596 24 fields · synced Oct 1, 2026