VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)

The VERITON CT 300/400 Series is a hybrid SPECT/CT imaging system for detecting, localizing, diagnosing, staging, and restaging lesions and diseases in cardiovascular, neurological, and trauma applications. It combines single-photon emission computed tomography (SPECT) for functional/physiological imaging with multislice CT for anatomical imaging, with outcomes used to plan, guide, and monitor therapy.

The subject device is identical to the predicate except for the addition of VERITAS.AI Noise Reduction, an optional deep-learning post-processing feature using a convolutional neural network (CNN) that reduces noise in reconstructed SPECT images only. The AI module preserves original images, does not alter quantitative values or raw data, requires no hardware or workflow changes, and includes three workflow-specific models (Bone-IQ.AI, Thera-IQ.AI, MIBG-IQ.AI).

IEC 62304 Class B SDLC, FDA software and cybersecurity guidance, IEC 81001-5-1, AAMI TIR57, AAMI TIR97, ISO 14971, IEC 62366-1, IEC 60601-1, IEC 60601-1-2, and NEMA NU-1:2023 for QC compliance.

The subject device has identical intended use, principles of operation, hardware configuration, and fundamental technology as the predicate (K230600). The optional VERITAS.AI feature is software-only and does not alter safety or effectiveness characteristics. Verification and validation testing on 106 patients demonstrated signal preservation (R² > 0.99), noise suppression (20–28% reduction), and blinded expert assessment showing equivalent or improved image quality with 92–100% inter-reader agreement, supporting substantial equivalence.