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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.<br>
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MRI Machine Manufacturing P R E S E N T E D B Y O P E R O N S T R A T E G I S T
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, AND RADIO WAVES MRI SCAN IS DISTINCTIVE FROM CT SCANS AND X-RAYS IN THAT IT DOES NOT EMPLOY POTENTIALLY DANGEROUS IONIZING RADIATION. WHAT ARE THE TYPES OF MRI MACHINES? CLOSED BORE MRI-THEY HAVE A RING OF MAGNET THAT FORMS A TUBE IN THE MIDDLE WHERE A PATIENT CAN LIE FOR IMAGES. THEY ARE NARROW AND MAY CAUSE ANXIETY AND DISCOMFORT FOR A FEW PEOPLE. OPEN BORE MRI- THIS HAS TWO FLAT MAGNETS POSITIONED OVER AND UNDER YOU WITH A LARGE SPACE IN BETWEEN WHERE A PATIENT CAN LIE FOR IMAGES.
FAQS What size room is required for an 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 must submit a 510(k) notification before marketing their MRI System. Operon Strategist will provide consultation 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 consultation to manufacturers to obtain CDSCO registration certification.
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