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510(k) Data Aggregation
K Number
DEN150004Device Name
EPIC ClearView System
Manufacturer
Date Cleared
2016-07-15
(549 days)
Product Code
Regulation Number
882.1561Why did this record match?
Product Code :
PNA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ClearView™ System provides two sets of numbers under two different conditions, one with capacitive barrier to minimize the effect of variables such as oils and perspiration on the image and one without the capacitive barrier. The device provides numerical measures of electrophysiological signals emanating from the skin. The device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions. This device is only to be used to image and document electrophysiological signals emanating from the skin. Clinical management decisions should be made on the basis of routine clinical care and professional judgment in accordance with standard medical practice.
Device Description
The ClearView System consists of the ClearView Device (hardware) attached to a computer/software system. The measurements are digital photographs acquired when placing a fingertip in contact with a glass electrode. A series of electrical impulses are applied to the glass electrode generating a localized electromagnetic field around the fingertip. Under the influence of this field, an image is generated. A software analysis of the images of the 10 fingers (including the thumbs) provides the inputs for an algorithm-driven Response Scale Report. The ClearView System provides numerical electrophysiological data to the healthcare professional. Any interpretation of this information is the responsibility of the healthcare professional; the device is limited to use as a measurement tool and is not intended for diagnostic purposes or for influencing any clinical decisions.
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