Subtle Medical, Inc.

Subtle Medical, Inc. specializes in AI-powered software tools designed to enhance and process medical imaging data. Their products include automated reconstruction algorithms for CT and PET scans, reformatting software for MRI data, synthetic imaging applications to create alternative MRI sequences, and workflow optimization tools for PET and MRI systems. These solutions are intended to improve imaging quality, efficiency, and diagnostic accuracy without requiring additional hardware.

Subtle Medical, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance framework, as its devices are authorized under both US (FDA) and European Union (MDR) standards.

Subtle Medical’s devices are listed in the FDA’s 510(k) clearance registry for US authorization and in the EU’s eudamed database under the Medical Device Regulation (MDR). These registries ensure transparency regarding the regulatory status of their imaging software and diagnostic tools.

Subtle Medical’s devices are classified as Class II and Class IIa under the EU Medical Device Regulation (MDR). This classification is based on their intended use in post-processing medical imaging, where they assist in diagnostic workflows but do not involve invasive procedures. The FDA categorizes these devices similarly under its 510(k) clearance process, reflecting their role as software-driven diagnostic aids.