What is MRI Machine?
Magnetic Resonance Imaging (MRI) creates detailed images of the organs and tissues within the body by using a powerful magnetic field and radio waves. MRI scan creates a detailed cross-sectional image of interior organs and structures using a powerful magnet, radio waves MRI scan is distinctive from CT scans and X-rays in that it does not employ potentially dangerous ionizing radiation.
X-rays, CT scans, and MRI are three popular imaging techniques.
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Difference Between X-Ray, CT Scan and MRI Scan Machine
X-ray | CT Scan | MRI scan |
2D images | 3D images | 3D images |
Most common widely available | Powerful than X-ray | Use powerful magnet & radio waves. |
Primarily used to see bones & detect cancer, pneumonia | Diagnose conditions organs & soft tissues | Mostly scan spine,breast,abdomen, neck |
What are the Types of MRI Machines?
- Closed Bore MRI-they have ring of magnet that forms tube in the middle where a patient can lie for images. They are narrow and may cause anxiety and discomfort for few people.
- Open Bore MRI- this has two flat magnets positioned over and under you with large space in between where a patient can lie for images.
How MRI Machine is Made?
The manufacturing process of MRI machines:
The components for MRI machines are magnets, gradient coils, RF (Radio frequency) system and Display.
a) Magnet: Superconducting electromagnets are used for MRI system. A basic design involves coil of conductive wire, cooling system and power supply. In a container with liquid helium, the coils are submerged. They become superconductive because of the drop in temperature caused by this. Two more vessels holding various coolants, such as liquid nitrogen, are placed around the first vessel to help maintain temperature stability. Then, in a vacuum-sealed container, this assembly is suspended using thin rods. The magnetic coils are connected to a power supply, which is only utilized to activate the magnet when it is necessary.
b) Gradient coils: There are three sets of gradient The gradient coils are electromagnets of the resistive type. Thin strips of copper or aluminum are wound in a precise way to create each coil. Epoxy is incorporated into the coils’ structure to increase their strength.
c) RF system: The MRI manufacturer can purchase the electronic parts for the RF (radio frequency) system from available sources. The RF coils which come in a variety of configurations are attached to these parts. The gradient coils’ material is also used in the transmitter and receiving coils. They are likewise built similarly to the primary magnet. A surface coil is one form of RF coil that is placed directly on the patient and has a circular shape.
d) Display: For usage in an MRI system, the display system is to display the data. The Fourier transformer, signal converter, user interface, and preamplifier are all connected to it. It is connected to the laser
Each component of the MRI is constructed and placed in a proper frame. In either situation, the magnet’s nature usually calls for additional handling considerations, including transporting it in an air-suspended vehicle.
Quality Control for MRI Machines:
MRI machine are regulated by different regulatory authorities depending upon the manufacturing site location.
CDSCO– Under the Directorate General of Health Services (DGHS) and Ministry of Health & Family Welfare, CDSCO is India’s leading regulatory authority for medicines and medical devices. MRI machines are classified as medical devices and their registration with CDSCO is mandatory. As per Indian CDSCO regulatory MRI machine is classified under notified Class C medical device.
European CE Marking– European CE marking is mandatory for medical devices to sell products in European countries. MRI machine is classified as Class II medical devices as per European regulation.
US FDA– U.S. Food and Drug Administration (FDA, is responsible for regulating medical devices in the United States. MRI machines fall under the category of Class II medical devices and go through the required regulatory procedure to get clearance or approval from the FDA before they market in the United States.
Why Choose an Operon Strategist in the Process of MRI Machine Manufacturing?
Operon Strategist is a medical device regulatory consultant for the last 12 years and has a global presence in 32 countries. We provide Turnkey Project Solutions for medical device manufacturing plant setup.
Different governmental bodies have set standards and performance suggestions for the Quality assurance. Documentation is required to prove the test, and if your documents don’t accurately reflect the results of your testing, It will be difficult to pass regulatory checks and obtain licenses. from designing the device to securing a license, our professional and experienced team will provide end-to end- help to manufacturers.
Our experience is demonstrated by our expanding number of happy customers and global presence. Speak to our experts about your regulatory needs to receive the best advice.
FAQs
What size room required for MRI?
In this case, the space needed to start is around 800-850 square feet. If you're adding an MRI suite to an existing facility with offices, hallways, and waiting areas already in place the space you'll need to reallocate or add on is around 650 square feet.
What is the FDA regulation for MRI?
The FDA takes a risk-based approach to medical device regulation, and MRI scanners are Class II (moderate risk) medical devices, meaning that an MRI manufacturer is required to submit a 510(k) notification prior to marketing their MRI System. Operon Strategist will provide consult to manufacturers to obtain FDA registration certification.
How do I register a medical device with CDSCO?
The application addressed to the Drugs Controller General (India) shall be deposited at the CDSCO, FDA Bhawan, Kotla Road, Near Mata Sundari College, ITO, New Delhi- 110002. Operon Strategist will provide consult to manufacturers to obtain CDSCO registration certification.
