Cartesion Prime (PCD-1000A/3) V10.21

The Cartesion Prime (PCD-1000A/3) V10.21 is a diagnostic imaging system combining Positron Emission Tomography (PET) and X-ray Computed Tomography (CT). It is used by trained healthcare professionals to acquire metabolic and functional images for evaluation, detection, diagnosis, staging, and therapeutic planning of oncological, cardiovascular, and neurological diseases. The device can also operate independently as a whole-body multi-slice CT scanner.

The subject device differs from the predicate (V10.15) in three ways: (1) expansion of AiCE-i for PET to include pediatric imaging with user-selectable intensity settings (Smooth, Standard, Sharp) instead of ON/OFF; (2) implementation of a Deviceless PET Respiratory gating system using a deep-learning neural network (AI mode) instead of Normal mode; and (3) respiratory gating is now extracted from PET data itself rather than requiring external devices.

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. Phantom testing followed NEMA NU-2 Section 7.

The Cartesion Prime V10.21 is substantially equivalent to the predicate V10.15 because both devices perform the same intended function (PET/CT imaging for diagnostic purposes) and the new features (pediatric AiCE-i and Deviceless PET Respiratory gating) are software enhancements that improve image quality and reduce motion artifacts without changing the fundamental device function or safety profile. Bench testing and clinical evaluations demonstrated that the new features maintain or exceed the performance characteristics (SUV accuracy, lesion detection, noise reduction) of the predicate device.