Imaging system of positron emission and X-ray computed tomography (DigitMI 930)

The DigitMI 930 is a PET/CT imaging system that combines positron emission tomography with X-ray computed tomography to produce attenuation-corrected PET images. It is intended for qualified healthcare professionals to image the distribution of positron-emitting radiopharmaceuticals for metabolic and physiologic assessment across various organ systems and disease states, including oncology, cardiology, and neurology applications. The system can also function as a standalone diagnostic CT imaging device.

The proposed device features a 72-ring LYSO detector for the PET component and 64 physical rows of detectors for the CT component, with continuous rotation and multiple scan modes (topo axial and helical). Performance specifications show differences from the predicate in sensitivity, NECR peak value, peak true count rate, scatter fraction, count rate bias, spatial resolution (FWHM), scan speed, and maximum table load, though the proposed device has been tested to verify measurement accuracy and effectiveness through performance testing and software validation.

The device was tested against IEC 60601-1:2020, IEC 60601-1-3:2021, IEC 60601-1-2:2020, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, NEMA NU 2:2018, NEMA XR 25:2019, NEMA XR 28:2018, IEC 60601-2-28:2017, IEC 60601-2-44:2016, IEC 61223-2-6:2006, IEC 61223-3-5:2019, NEMA PS3.1-3.20:2022d, and ISO 60825-1:2014.

The proposed device meets the same regulatory classification (Class II), uses identical product codes (KPS, JAK), and is governed by the same regulations (21 CFR 892.1200 and 892.1750) as the predicate Discovery MI. Although performance specifications differ, these differences are characterized as slight variations that do not substantially influence effectiveness and safety, as demonstrated by the device's compliance with applicable safety and performance standards. The basic design principle, usage, and intended indications are the same between the proposed device and predicate, with differences attributable to refinements in detector technology and measurement capabilities rather than fundamental changes in intended function.