Planmed Clarity 2D, Planmed Clarify S

The Planmed Clarity 2D and Clarify S systems include both single-use and reusable components, depending on the specific configuration chosen. Since they are not sterile by default, proper handling, storage, and maintenance are required as outlined in the manufacturer’s guidelines to ensure safety and performance. Reusable parts must be cleaned and maintained according to Planmed’s instructions to prevent contamination and maintain imaging accuracy.

The Planmed Clarity 2D and Clarify S systems have been authorized through FDA 510(k) clearance, demonstrating they are substantially equivalent to a predicate device. They also comply with the Medical Device Directive (MDD) and the Medical Device Regulation (MDR), meeting international regulatory requirements for mammographic imaging equipment. These systems are classified as Class II devices, adhering to strict standards for imaging accuracy and patient safety.

Each variant of the Planmed Clarity 2D and Clarify S systems is assigned unique FEI numbers (e.g., 3001722928, 3009717300, etc.) for traceability and regulatory tracking. These numbers help distinguish between different configurations and ensure compliance with manufacturer specifications, maintenance protocols, and warranty terms. Checking the FEI number allows you to confirm the exact model and access relevant documentation.

Maintenance and cleaning procedures for reusable components are detailed in the manufacturer’s instructions provided by Planmed Oy. Since these systems are not sterile by default, adherence to these guidelines is critical to prevent cross-contamination and ensure consistent imaging quality. Contacting Planmed’s support team or referring to the user manuals will provide the specific protocols for your system’s configuration.