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510(k) Data Aggregation
K Number
K152727Device Name
ISEN-Goggles
Manufacturer
Date Cleared
2016-04-26
(217 days)
Product Code
Regulation Number
882.1460Why did this record match?
Applicant Name (Manufacturer) :
**ISEN TECH **& TRADING COMPANY, LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ISEN-Goggles are used to record and visually display movements of the eyes including nystagmus.
Device Description
This device consists of patient eye goggles with an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USB port to facilitate transfer of data captured and stored in the device's SD-type memory.
The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for nearsimultaneous viewing of the video images from both eyes on the attached LCD screen.
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