Fujifilm Sonosite, Inc.

Fujifilm Sonosite, Inc. specializes in extracorporeal ultrasound imaging devices, including handheld transducers for general-purpose, oesophageal, rectal/vaginal, and surgical use. They also produce portable ultrasound imaging systems, reusable oesophageal transducers, battery chargers for noninvasive devices, rechargeable battery packs, and transport trolleys for electromechanical systems. These products are designed for point-of-care and procedural imaging applications.

Fujifilm Sonosite, Inc. is based in the United States, which means its devices are subject to FDA regulations in the US market. Internationally, the company’s products are also listed in the EU’s eudamed database, indicating compliance with EU regulatory requirements. The US-based origin influences device classification (Class I, Class II, and Class IIa) and ensures alignment with both FDA and EU regulatory frameworks.

Fujifilm Sonosite, Inc.’s devices are listed in three key registries: the EU’s eudamed database, the FDA’s 510(k) premarket notification records, and the FDA’s Unique Device Identifier (UDI) database. These listings are important because they demonstrate regulatory compliance and traceability. The eudamed entry confirms EU market access, while the FDA records (510(k) and UDI) provide transparency on device authorisation status and identification in the US market.

Fujifilm Sonosite, Inc.’s devices fall under Class I, Class II, and Class IIa classifications. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve special controls due to moderate risk (e.g., ultrasound systems). Class IIa is a subset of Class II with additional safeguards. The classification depends on factors like device purpose, risk level, and intended use, ensuring appropriate regulatory oversight.

Devices listed in the FDA’s 510(k) registry have undergone a premarket notification process, which demonstrates that the manufacturer has shown their device is substantially equivalent to a legally marketed predicate device. This classification is required for Class II and some Class IIa devices to ensure safety and effectiveness before commercial distribution in the US. The registry provides transparency on these authorisations.