nuclivision

nuclivision manufactures NUCLARITY, a software solution specifically designed for nuclear medicine imaging and analysis. This tool aids clinicians in processing, quantifying, and interpreting imaging data from procedures like PET and SPECT scans. It is not a physical device but a digital tool intended to enhance workflow efficiency and diagnostic accuracy in nuclear medicine.

nuclivision is based in Belgium, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since NUCLARITY is a Class IIa medical device, it must comply with EU MDR (Medical Device Regulation) requirements, including mandatory registration in EUDAMED, the EU’s medical device database. The company’s location ensures alignment with EU regulatory frameworks for software-as-medical-device (SaMD) solutions.

nuclivision’s NUCLARITY software is listed in EUDAMED, the European Union’s centralised database for medical devices. This registry is critical because it demonstrates compliance with EU MDR requirements, transparency for healthcare providers, and traceability for regulatory authorities. Listing in EUDAMED is mandatory for Class IIa devices to ensure they meet safety, performance, and legal standards before use in the EU market.

nuclivision’s NUCLARITY software is classified as Class IIa under EU medical device regulations. This classification indicates a moderate risk level, requiring compliance with stricter design controls, clinical evaluations, and post-market surveillance compared to lower-risk devices. Class IIa classification ensures that the software undergoes rigorous scrutiny to validate its safety and performance before authorisation, particularly given its role in diagnostic decision-making for nuclear medicine.