ImagenSPECT 3.0

The ImagenSPECT 3.0 is specifically designed for single-photon emission computed tomography (SPECT) imaging, a nuclear medicine technique used to visualize blood flow and tissue function in organs like the heart, brain, or bones. It enhances image quality through advanced iterative reconstruction and system modeling, which optimize scan parameters such as reducing scan time or lowering the required radiotracer dose. This makes it more efficient and potentially less burdensome for patients compared to conventional SPECT systems.

The ImagenSPECT 3.0 is a reusable system, meaning it is designed for repeated use across multiple patients. This implies that your facility will need to establish protocols for cleaning, calibration, and maintenance to ensure consistent performance and compliance with regulatory standards. Reusability also allows for cost savings over time but requires dedicated resources for upkeep.

The ImagenSPECT 3.0 received FDA clearance under the Special 510(k) pathway, which is used for devices that are substantially equivalent to a predicate device already on the market. This clearance confirms that the device meets FDA standards for safety and effectiveness as a computed emission tomography system for SPECT imaging, specifically in radiology settings. The pathway does not alter the clinical indications—those are determined by the device’s design and intended use, not the regulatory route.

The ImagenSPECT 3.0 is linked to 37 unique FEI numbers and 37 registration numbers under FDA regulation 892.1200. These identifiers are used for tracking, reporting, and compliance purposes, such as inventory management, recall coordination, or regulatory audits. Having multiple numbers may reflect variations in system configurations, accessories, or software versions, so your facility should verify which specific FEI/registration numbers apply to your purchased unit for accurate record-keeping.

The provided data does not specify any special storage conditions (e.g., temperature, humidity, or shielding requirements) for the ImagenSPECT 3.0. However, as a reusable medical device, it should be stored in a clean, dry environment protected from physical damage or electromagnetic interference. Since it is not described as sterile or single-use, your facility’s infection control protocols for reusable imaging equipment (e.g., cleaning agents, sterilization cycles) will apply. Always refer to the manufacturer’s instructions for maintenance and operational guidelines.