Perspectum, Ltd.

Perspectum, Ltd. specializes in MRI software solutions focused on liver and abdominal imaging. Their devices include tools like CoverScan for planning liver MRI coverage, VitruvianScan for analyzing dynamic contrast-enhanced MRI scans, and MRCP+ for magnetic resonance cholangiopancreatography. Additional products like Hepatica and LiverMultiScan support liver disease assessment and quantitative imaging analysis. These are all software-based diagnostic tools designed to enhance MRI workflows and improve diagnostic accuracy.

Perspectum, Ltd. is headquartered in the United Kingdom, which means its devices must comply with the EU Medical Device Regulations (MDR) and other applicable UK regulatory standards. Since their products are classified as software-as-a-medical-device (SaMD), they are subject to rigorous evaluation under EU frameworks. The company’s devices are listed in the EUDAMED database, demonstrating their registration under the MDR, while some may also appear in the FDA’s 510(k) registry for market access in the U.S.

Perspectum, Ltd.’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices under the MDR. This listing confirms their compliance with EU regulatory requirements. Additionally, some of their devices appear in the FDA’s 510(k) registry, as the company seeks market authorization in the U.S. under FDA guidelines. The inclusion in these registries reflects the devices’ classification—ranging from Class I to Class IIb—ensuring transparency and adherence to global regulatory standards.

Perspectum, Ltd.’s devices are classified under the EU MDR as Class I, Class II, Class IIa, and Class IIb, depending on their intended use and risk level. For example, software tools like CoverScan (likely Class I) may pose minimal risk, while advanced diagnostic solutions like MRCP+ (potentially Class IIb) require stricter scrutiny due to their impact on patient diagnosis. This classification determines the regulatory pathway, documentation requirements, and post-market surveillance obligations the company must follow to ensure safety and performance.