Classification by the Food and Drug Administration (FDA) of medical devices according to potential risks or hazards.

A defibrillator is a medical device used to re-establish the normal heartbeat with a jolt of electricity. Implantable cardioverter defibrillators (ICDs) are small devices that are placed below the collarbone and via wires, or leads continuously monitor the heart's rhythm.

E-Z-EM, Inc. is headquartered in New York and develops, manufactures and markets diagnostic imaging products.
The business of E-Z-EM encompasses CT imaging, virtual colonoscopy, gastro devices and accessories, and healthcare decontaminants. E-Z-EM is also a third-party contract manufacturer of contrast media. The company provides contract manufacturing services in various product areas, including pharmaceuticals, and cosmetics, as well as the marketing of radiological medical devices, such as entry biopsy needles and mammography wipes and related accessories.
Bracco Diagnostics, Inc. , the US-based subsidiary of Bracco Imaging S.p.A. and part of the Bracco Group, announced in Oct. 2007 that it has entered into a merger agreement to acquire E-Z-EM, Inc. (NASDAQ: EZEM) for a total consideration of about $ 240 million . Upon completion of the procedure and subject to the approval of the regulatory authorities, Bracco Diagnostics Inc. will incorporate E-Z-EM.

(FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.
For more details please visit the FDA's 'Our Mission and Mandate'.

See also Class I II III Devices and Phase 1 2 3 4 Drug Trials.

An acceptance checking is the condition inspection that takes place after a new installation or repair from nuclear-medical devices. Those results must be compared and agree with the provided data of the manufacturer.