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510(k) Data Aggregation
K Number
K003442Device Name
MODIFICATION TO EDI VERIS SYSTEM
Manufacturer
ELECTRO-DIAGNOSTIC IMAGING, INC.
Date Cleared
2001-05-04
(179 days)
Product Code
HLX
Regulation Number
886.1630Why did this record match?
Applicant Name (Manufacturer) :
ELECTRO-DIAGNOSTIC IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K983983Device Name
EDI VERIS SYSTEM
Manufacturer
ELECTRO-DIAGNOSTIC IMAGING, INC.
Date Cleared
1999-02-03
(86 days)
Product Code
HLX
Regulation Number
886.1630Why did this record match?
Applicant Name (Manufacturer) :
ELECTRO-DIAGNOSTIC IMAGING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VERIS system is an electodiagnostic device used to generate photic signals and to measure and display the electrical signals generated by the retina and the visual nervous system. It displays digitized electroretinogram (ERG) and visual evoked potential (VEP) signals, power spectra, and topographic maps. These functions are controlled and interpreted by trained medical professionals. The device is intended for use in the diagnosis and management of retinal ischemic diseases, diabetic retinopathy, and central or branch vein occlusion.
Device Description
Photic stimuli are presented to the patient on a CRT screen up to 60 degrees at 241 elements in separately stimulated fields. Various modes are available for preferential stimulation of different retinal mechanisms and isolation of signal from different retinal layers. Data is acquired by 2 recording channels using conventional EEG electrodes (not provided with the device). During the period of time that the system is acquiring data (4-16 minutes), there is a real time display of the raw and processed data presented to the user. Once the resulting individual waveforms are acquired, 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 representations.
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