Arineta , Ltd.

Arineta, Ltd. specializes in full-body computed tomography (CT) systems. Their portfolio includes imaging devices like the SpotLight, SpotLight Duo, and CardioGraphe, which are designed for cardiac assessments and low-dose imaging. Some models, such as the SpotLight Duo with DLIR (Dual Low-Dose Imaging Reconstruction) or the SpotLight/SpotLight Duo with a low-dose lung cancer screening option, are tailored for specific diagnostic needs like lung cancer detection.

Arineta, Ltd. is based in the United States. Their devices are specifically designed and intended for use within the U.S. regulatory environment, where they undergo evaluation through programs like the FDA’s 510(k) and UDI (Unique Device Identification) systems.

Arineta, Ltd.’s devices are listed under the FDA’s 510(k) premarket notification program and the UDI system. These registries ensure traceability and compliance with U.S. regulatory requirements for medical devices. The 510(k) program is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, while UDI provides a unique identifier for tracking devices throughout their lifecycle.

Arineta, Ltd.’s devices fall under the FDA’s Class II regulatory category. This classification applies to devices that generally pose moderate risk and require special controls in addition to general controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) to demonstrate equivalence to a predicate device before they can be marketed in the U.S.