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In 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) expanded the FDA's authorities and strengthened the Agency's ability to safeguard and advance public health. Among other authorities, FDASIA permitted FDA to publish regulations establishing a Unique Device Identification (UDI) system for medical devices.
MIL-STD-130, "Identification Marking of U.S. Military Property," is a specification that describes markings required on items sold to the Department of Defense (DoD), including the addition, in about 2005, of UII (unique item identifier) Data Matrix machine-readable information (MRI) requirements.
Schematic diagram of a conventional MRI scanner. Not shown are the electronic control systems and service plant (chillers, etc.) these are usually installed in a seperate room. 19:42, 6 January 2007: 2,980 × 4,213 (34 KB) ChumpusRex: Schematic diagram of a conventional MRI scanner.
All patients are reviewed for contraindications prior to MRI scanning. Medical devices and implants are categorized as MR Safe, MR Conditional or MR Unsafe: [6] MR-Safe – The device or implant is completely non-magnetic, non-electrically conductive, and non-RF reactive, eliminating all of the primary potential threats during an MRI procedure.
Interventional magnetic resonance imaging, also interventional MRI or IMRI, is the use of magnetic resonance imaging (MRI) to do interventional radiology procedures.. Because of the lack of harmful effects on the patient and the operator, MR is well suited for "interventional radiology", where the images produced by an MRI scanner are used to guide a minimally-invasive procedure ...
Medication that have label indications mean that they were approved by the FDA. This means that they are clinically significant for the indication and manufacturers are allowed to market their drug for the indication. [2] A drug can have more than one FDA labeled indication, which means that it can be used for multiple medical conditions. [5]
This article needs to be updated.The reason given is: the section related to E.U. needs further updates (esp. in sections 3.2 and 4.2.2) as the directives 93/42/EEC on medical devices and 90/385/EEC on active implantable medical devices have been fully repealed on 26 May 2021 by Regulation (EU) no. 2017/745 (MDR); furthermore, Brexit triggers updates in these sections (U.K. developed their own ...
Modern 3 Tesla clinical MRI scanner.. Magnetic resonance imaging (MRI) is a medical imaging technique mostly used in radiology and nuclear medicine in order to investigate the anatomy and physiology of the body, and to detect pathologies including tumors, inflammation, neurological conditions such as stroke, disorders of muscles and joints, and abnormalities in the heart and blood vessels ...