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510(k) Data Aggregation
K Number
K023525Device Name
RETISCAN, RETIPORT
Manufacturer
ROLAND CONSULT
Date Cleared
2004-03-26
(522 days)
Product Code
GWE
Regulation Number
882.1890Why did this record match?
Applicant Name (Manufacturer) :
ROLAND CONSULT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrophysiological Test Unit for quantifying the retinal response, measuring a parameter (VEP) related to retinal response
Device Description
Photopic stimuli are presented to the patient on an VGA-screen at a various number of elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanism and isolation of signal from different retinal layers. Data are required by up to 8 recording channels using conventional EEGelectrodes. During the period of time that the system is aquiring data (1-20 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are aquired, the signals are analyzed by software using algorithms for spatial filtering and artifact rejection. Data may be presented in a number of forms, including waves recorded at each of the points tested, color plots, or 3D topographical representation.
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