Planmed Verity

The Planmed Verity is a mammography system specifically designed for digital breast imaging, allowing radiology departments or imaging centers to capture high-resolution X-ray images of breast tissue. It is intended for diagnostic purposes only, helping clinicians evaluate breast abnormalities, screen for breast cancer, and monitor known conditions.

The Planmed Verity is a non-reusable system, meaning it is not intended for reprocessing or reuse after a single use cycle. Since it is a complex imaging device, maintenance involves regular calibration and servicing as per the manufacturer’s guidelines to ensure consistent performance and image quality. The system is not sterile, so standard radiology hygiene protocols apply.

The Planmed Verity is identified by its Basic UDI (6430035430015L) and version number (1). This unique identifier ensures traceability and helps confirm compatibility with software updates, maintenance contracts, or spare parts. Always verify the UDI and version against the manufacturer’s documentation or support team to avoid mismatches.

As a non-sterile, non-reusable system, the Planmed Verity does not require specialized sterilization storage. However, it should be stored in a clean, dry environment protected from dust, moisture, and extreme temperatures to prevent damage to its components. Follow Planmed Oy’s guidelines for environmental conditions and avoid exposing the system to conditions that could compromise its calibration or functionality.

The Planmed Verity is authorized under FDA 510K and MDR (Medical Device Regulation) compliance, meaning it meets the regulatory standards for Class IIb diagnostic imaging devices in the U.S. and EU markets, respectively. For specific regional requirements, consult the manufacturer’s documentation or contact Planmed Oy directly, as compliance may vary by jurisdiction (e.g., additional local certifications may apply).