Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems

The Biograph Vision and Biograph mCT PET/CT systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners that provide fused metabolic and anatomic imaging. These systems are intended for whole-body oncology, neurology, and cardiology examinations to aid in detecting, diagnosing, staging, and restaging lesions, tumors, and disease, and can be used for low-dose lung cancer screening in high-risk populations.

The subject devices (VG85 software) have the same design, materials, energy source, and control mechanisms as the predicate devices (VG80 software), with modifications limited to software features (FAST Bolus, FAST 4D, FAST Applications, Automatic Patient Instructions, additional protocols, and kV settings for Tin Filtration) and computer hardware updates due to obsolescence. No features from the predicate have been removed, and the fundamental scientific technology remains unchanged.

PET performance testing was conducted in accordance with NEMA NU2-2018 standard. Risk management follows ISO 14971. The systems adhere to IEC 60601-1 series, 21 CFR 1020.30, and 21 CFR 1020.33 to minimize electrical, mechanical, and radiation hazards.

The devices are substantially equivalent because the indications for use, intended use, and fundamental technological characteristics are identical to the predicate device. All performance testing met predetermined acceptance values and showed the subject devices are comparable to the predicate in technological characteristics, safety, and effectiveness. The software feature updates and hardware changes do not raise new questions of safety and effectiveness, as similar modifications were cleared in reference predicate devices (K231833, K223547, K230421), and verification and validation testing substantiates these claims.