AnyScan 3.0 NM Scanner Family

The AnyScan 3.0 NM Scanner Family is a multimodal medical imaging system that combines SPECT, CT, and PET imaging capabilities in various configurations. It is intended for use by trained healthcare professionals to detect, localize, diagnose, stage and restage lesions, tumors, and diseases including cardiovascular disease, neurological disorders, and cancer, as well as aid in radiotherapy treatment planning.

The device uses similar materials, energy sources, and fundamental technology as the predicate devices (Symbia 6.7 and Biograph Horizon). Key differences include variations in detector types and configurations—3/8" and 5/8" crystal detectors with different numbers of photomultiplier tubes (PMTs)—but these do not raise different questions of safety and effectiveness. All modalities maintain independent functionality while supporting image registration and attenuation correction.

NEMA NU 1-2018 for SPECT performance, NEMA NU 2-2018 for PET performance, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-1 and IEC 62366-1 for electrical/mechanical/thermal safety, ISO 10993-1 for biocompatibility, IEC 62304 for software verification, and ISO 14971 for risk management.

The AnyScan 3.0 NM Scanner Family is substantially equivalent because it has similar indications for use and intended use as the predicate devices, employs similar technological characteristics with only minor detector variations that do not raise different safety or effectiveness questions, and performance testing confirms it meets or exceeds predicate acceptance values across all modalities (SPECT, CT, and PET).