The Optomap allows for a more comfortable retinal exam. Panoramic 200 Retinal Image - Click for hi resolution image. The top image to the right compares the doctor's view of your eye through an undilated pupil with an instrument called a direct ophthalmoscope (inner ring).
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
device(Noun) Any piece of equipment made for a particular purpose, especially a mechanical or electrical one. There are a number of household devices in a kitchen such as a dishwasher, a garbage disposal, or an electric can opener. device(Noun) A project or scheme, often designed to deceive; a stratagem; an artifice.