Aquilion Prime

• • Ongoing Z-1723-2020 FDA Class II ·initiated 25 Mar 2019

  Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.

• • Terminated Z-0017-2016 FDA Class II ·initiated 8 May 2015

  If two specific operations are performed in multi-phase helical scanning, the acquired raw data may not be saved.

510(k) Number

K120710 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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• What types of medical imaging studies is the Aquilion Prime CT scanner primarily used for in clinical practice?

  The Aquilion Prime is designed for high-resolution cross-sectional imaging, making it suitable for detailed evaluations in radiology. Clinically, it supports applications like cardiovascular assessments (e.g., coronary artery imaging), abdominal scans (e.g., liver or pancreatic studies), and neurological examinations (e.g., brain or spinal imaging). Its 80-slice capability ensures precise visualization for diagnostic purposes in these areas.

• Is the Aquilion Prime CT scanner intended for use in outpatient clinics, or is it meant for hospital radiology departments only?

  The Aquilion Prime is explicitly intended for use in radiology departments within community and regional hospitals, as specified in its description. While it is not explicitly excluded from other settings, its design and scale align with hospital environments where comprehensive diagnostic imaging is performed.

• How is the Aquilion Prime CT scanner supplied, and what does that mean for maintenance and cleaning?

  The Aquilion Prime is supplied as a reusable, non-sterile medical system. This means it is built for repeated use in clinical settings but does not require sterile packaging or single-use components. Proper installation, maintenance, and adherence to manufacturer guidelines are essential to ensure reliability and safety, as it is not designed for sterile procedures.

• Can the Aquilion Prime be used in environments where MRI equipment is also present, and what safety considerations apply?

  Yes, the Aquilion Prime operates within standard MRI safety parameters for non-ferromagnetic environments. This means it can coexist in facilities with MRI machines, provided it is used in areas compliant with non-ferromagnetic safety protocols. However, it is not classified as MRI-compatible for procedures involving magnetic fields, so caution must be exercised to avoid interference or safety risks.

• What does the FDA clearance (K120710) for the Aquilion Prime imply about its regulatory pathway and intended use?

  The FDA clearance (K120710) under a Special 510(k) pathway with a decision of Substantially Equivalent (SESE) indicates that the Aquilion Prime has been evaluated and deemed comparable to legally marketed predicate devices in terms of safety and effectiveness. This clearance confirms its regulatory compliance for use in radiology departments as described, but it does not expand its intended use beyond what is explicitly stated in the device’s labeling and manufacturer instructions.