ADAS3D

The ADAS3D is designed for use in clinical settings like radiology departments, where it provides three-dimensional (3D) imaging of anatomical structures for detailed visualization and clinical assessment. As a diagnostic imaging system, it enables precise visualization to aid in diagnostic evaluations, though its specific clinical applications are determined by the operator based on the imaging results.

No, the ADAS3D is non-reusable and intended for single-use applications. This means each unit is designed for one use only, and after use, it must be disposed of according to facility protocols. Since it’s non-reusable, there are no maintenance or reprocessing requirements—simply replace it with a new unit for subsequent imaging sessions.

The ADAS3D must be stored and handled strictly according to the manufacturer’s guidelines to maintain its functionality and safety. While the data does not specify exact storage conditions (e.g., temperature or humidity), compliance with these instructions is critical, as improper storage could compromise performance or integrity before use.

The ADAS3D has been authorized through FDA 510(k), MDD (Medical Device Directive), and MDR (Medical Device Regulation) pathways, confirming its compliance with stringent regulatory standards in the U.S. and EU markets. Buyers should verify local regulatory requirements, as these authorizations ensure the device meets safety and performance criteria for its intended diagnostic imaging use.

Each ADAS3D unit carries a unique Basic UDI (B-08437021722017) and associated UDI data (e.g., `01FH8ME1JE15E3SYDC7EGEFK28`). The UDI helps track the device’s identity, batch, and serial number for traceability, ensuring proper inventory management and compliance with regulatory traceability requirements. This is particularly useful for recalls or post-market surveillance.