From Agile Magnetics
Medical Original Equipment Manufacturers (OEMs) are required to
submit an FDA Section 510 (k) application when they plan to market
a new equipment design. Section 510 (k) of the U.S. Food, Drug and
Cosmetic Act allows the FDA to determine whether the device is
equivalent to similar equipment already on the market.
The custom transformers that power these medical devices, and are
vital to their function, often demand extremely rare raw materials
and stringent manufacturing processes that can take weeks to
complete, causing lengthy delays in an OEM's production process.
Products & Services
Transformers
Transformers are electrical devices that are designed to transfer energy from one circuit to another by electromagnetic induction. They are used typically to increase or decrease voltage as it passes from one side of the device through the other.
Signal Transformers
Signal transformers transfer information from one circuit to another by electromagnetic induction. They are used to increase or decrease the voltage from one side of a power transformer to the other.
Power Transformers
Power transformers convert power-level voltages from one level or phase configuration to another. They can include features for electrical isolation, power distribution, and control and instrumentation applications.
Toroidal Transformers
Toroidal transformers typically consist of copper wire wrapped around a cylindrical core. This design prevents the magnetic flux that occurs within the coil from leaking.
Topics of Interest
Medical Imaging: The Basics of FDA Regulation Devices that use medical imaging are increasingly prevalent. OEMs must know how to navigate the regulatory pathway to get such devices approved.
When to submit a 510(k) Companies wishing to market medical devices in the United States (US) must determine whether or not the Food and Drug Administration (FDA) has classified their devices and, if...
Medical Device & Diagnostic Industry t FDA, a major effort is under way to streamline the process by which medical devices are reviewed. Review protocols have been changed so that deficient...
e-510(k) submissions on the horizon If all goes according to plan, the regulation of IVDs will soon be entering the electronic age. For the past year, FDA�s Office of In Vitro Diagnostic Device...
The United States (US) Food and Drug Administration (FDA) requires that companies provide sufficient evidence to demonstrate that medical devices are safe and effective. In many cases, test data must...
