BIOGRAPH One

The BIOGRAPH One is an integrated PET-MR imaging system that combines positron emission tomography (PET) with magnetic resonance imaging (MRI). It is used for noninvasive diagnostic imaging to evaluate metabolic and physiologic functions for diseases including cardiovascular disease, neurological disorders, and cancer. The system uses MRI for radiation-free attenuation correction maps and provides fused anatomically-aligned PET-MR images.

The device includes new and modified hardware components (new coils, Smart Distribution Box, updated RF transmitter TBX3, modified detector cassettes) and extensive new software features (Fast Whole-Body and Head workflows, Deep Resolve Boost/Sharp AI features, myExam Assist tools, Ultra HD-PET, OpenRecon 2.0). While there are technological differences from the predicate device, the subject device maintains equivalent operational environment, programming language, operating system, and overall performance profile with enhanced state-of-the-art capabilities.

Testing conformed to IEC 62304 (medical device software lifecycle), IEC 60601-1 and IEC 60601-2-33 (electrical safety and MR equipment), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), NEMA MS 4-2010 (acoustic noise), NEMA MS 9-2008 (phased array coils), NEMA PS 3.1-3.20 (DICOM), and NEMA NU 2-2024 (PET performance measurements).

BIOGRAPH One is substantially equivalent to the predicate device Biograph mMR (K200213, cleared May 2020) and reference devices (MAGNETOM Vida, Cima.X, Sola, and Biograph Vision PET/CT). Despite hardware and software modifications to incorporate state-of-the-art technology, nonclinical testing (software verification/validation, sample clinical images, performance bench tests, electrical/mechanical/safety testing) demonstrates the new features bear equivalent safety and performance profiles to the predicate device.