Aquilion ServeSP (TSX-307B) V2.0

The Aquilion Serve SP (TSX-307B) V2.0 is a computed tomography (CT) X-ray system that acquires and displays cross-sectional images of the whole body, including the head. It can provide volume sets for specialized studies performed by trained physicians and includes three AI-based image reconstruction algorithms: AiCE (noise reduction), PIQE (spatial resolution enhancement), and CLEAR Motion (motion artifact reduction) for various anatomical applications.

The subject device differs from the predicate (Aquilion Serve SP V1.3) by implementing two new features: PIQE reconstruction for cardiac, body, and lung applications, and CLEAR Motion reconstruction for body and lung applications. Both are deep learning reconstruction (DLR) methods using deep convolutional neural networks (DCNN) to improve image quality; PIQE was previously cleared under K242403 and CLEAR Motion was also previously cleared under K242403.

The device conforms to IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC81001-5-1, IEC62366-1, NEMA XR-25, NEMA XR-26, NEMA XR-29, NEMA NU-2, and radiation safety standards in 21 CFR §1010 and §1020. The device is designed and manufactured under 21 CFR §820 and ISO 13485 Quality System Regulations.

The subject device is substantially equivalent to the predicate because both devices perform the same intended function of acquiring and displaying cross-sectional CT volumes. The only differences are the addition of PIQE and CLEAR Motion reconstruction algorithms, both of which were previously cleared by the FDA on other Canon CT systems. Performance testing demonstrated that these algorithms maintain CT number accuracy, do not introduce artifacts, and improve image quality without changing the fundamental device design or operation.