Device Description (DD)#

!!This Section is Work in Progress.!!

Overview of the System#

The A4IM scanner is an innovative low-field Magnetic Resonance Imaging (MRI) device, specifically designed for high-quality imaging of the human head and extremities. Utilizing permanent magnets, the A4IM scanner distinguishes itself from traditional high-field MRI systems that use superconducting magnets. This low-field approach allows for a more compact design and reduced operational costs while still providing detailed images. The system is intended for use in healthcare facilities such as hospitals, clinics, and diagnostic centers.

The A4IM scanner comprises several key components that work in harmony to deliver high-resolution imaging capabilities:

Permanent Magnets: Provide the B0 magnetic field required for imaging, offering a compact and cost-effective solution compared to superconducting magnets.

Radiofrequency (RF) Coils: Essential for both transmitting and receiving signals necessary to generate images, these coils are designed for optimal sensitivity and image quality.

Gradient Coils: Responsible for spatial encoding of the MRI signals, these coils allow for precise image localization and resolution, which is crucial for accurate diagnostics.

Patient Table: Designed with patient comfort and safety in mind, the table ensures optimal positioning during scans.

MRI Console: This component houses the computer system and reference cards essential for controlling the MRI hardware and managing the acquisition process. It serves as the central hub for system operation.

MRI SanHub Software (Cloud-based): A cutting-edge platform that provides advanced image reconstruction and review capabilities. This software seamlessly integrates with the MRI console, enhancing the overall functionality and user experience.

Intended Use#

The A4IM scanner is intended to aid healthcare professionals as an additive support measurement to trigger further investigation. It is designed to assist in the imaging of the human head and extremities, providing high-quality images that can be interpreted by trained physicians. The device is particularly useful in the diagnostic process, although it is not intended for quantitative measurements.

Intended User Population#

The primary users of the A4IM scanner are radiologists, MRI technicians, and other healthcare professionals trained in medical imaging. The device is designed to be user-friendly and intuitive, ensuring ease of use for the intended user population.

Contraindications#

The A4IM scanner is contraindicated for patients with certain types of metal implants, electronic devices such as pacemakers, or any other condition that may pose a risk due to the magnetic field.

Treatment Specifications#

The A4IM scanner is intended for patients requiring diagnostic imaging of the head and extremities. Patient selection criteria and field of application should be determined by the healthcare provider based on the individual patient’s medical condition and imaging needs.

Proposed Conditions of Use#

The A4IM scanner is intended for use in a controlled clinical environment by trained professionals. The device should be operated according to the manufacturer’s instructions and applicable surgical techniques.

Explanation of Features#

The A4IM scanner includes advanced features such as high-resolution imaging, fast scanning times, and a user-friendly interface. The system is designed for optimal patient comfort and safety.

Configurations#

The A4IM scanner is available in various configurations to meet the diverse needs of healthcare facilities.

List of Devices Subject to Clearance#

TBD: list of devices and components that require regulatory clearance.

Novel Features#

TBD: The A4IM scanner incorporates novel features such as advanced image processing algorithms and enhanced RF coil technology for superior image quality.

Principles of Operation#

The A4IM scanner operates on the principles of magnetic resonance, where hydrogen atoms in the body are aligned by a magnetic field and then perturbed by radiofrequency pulses. The resulting signals are processed to create detailed images of the internal body structures.

Mode of Action#

The device’s mode of action involves non-invasive imaging through magnetic resonance, providing detailed anatomical information without the use of ionizing radiation.

Key Functional Elements#

The A4IM scanner comprises several key functional elements that work in harmony to deliver high-resolution imaging capabilities:

Patient Table: Designed with patient comfort and safety in mind, the table ensures optimal positioning during scans.

MRI Hardware: Permanent magnets, RF coils, and gradient coils for image acquisition.

MRI Console: Controls the MRI hardware and manages the acquisition process.

MRI SanHub Software: Cloud-based platform for image reconstruction and review.

List of Components and Accessories#

TBD: A comprehensive list of components and accessories marketed with the A4IM scanner.

Interoperability and Compatibility#

The A4IM scanner is designed for interoperability with existing healthcare systems, ensuring seamless integration and data exchange.

Safety Class#

The A4IM scanner is classified as a Class 2a medical device.

Level of Concern#

The device is categorized as Level B concerning safety concerns. It is important to note that the A4IM scanner poses risks related to projectiles/flying objects and Specific Absorption Rate (SAR) heating.

The A4IM scanner represents a significant advancement in low-field MRI technology, offering healthcare professionals a powerful tool for diagnostic imaging. Its innovative features, combined with a focus on patient safety and comfort, make it a valuable addition to any medical imaging facility.

Notes#

  • Support for further investigation

  • research device (investigational vs research)

  • MR is not a quantitative measurement

  • abbild vom menschlichen gewebe

The A4IM scanner is intended to aid professionals as an additive support measurement to trigger further investigation.

The A4IM scanner is intended to be used as an additive support measure without any diagnostic relevance for human brain and extremity imaging.

Internal structure of the internal body.

which can be interpreted by a trained physician and can be useful in the diagnostic process.

safety class 2a

Level of Concern: B

  • projectiles/flying objects

  • SAR heating

  • cannot be quenched