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510(k) Data Aggregation
K Number
K143211Device Name
myVision Track Model 005
Manufacturer
VITAL ART AND SCIENCE INCORPORATED
Date Cleared
2015-03-20
(130 days)
Product Code
HOQ, HOO, HPT
Regulation Number
886.1330Why did this record match?
Applicant Name (Manufacturer) :
VITAL ART AND SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The my VisionTrack® Model 0005 is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including age-related macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrack® Model 0005 is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
Device Description
The myVisionTrack® Model 0005 is a vision function test provided as a downloadable app on to the user's supplied cell phone or tablet. The myVisionTrack® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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K Number
K121738Device Name
MYVISIONTRACK(TM)
Manufacturer
VITAL ART AND SCIENCE INCORPORATED
Date Cleared
2013-02-22
(254 days)
Product Code
HOQ, HPT
Regulation Number
886.1330Why did this record match?
Applicant Name (Manufacturer) :
VITAL ART AND SCIENCE INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The my Vision TrackTM is intended for the detection of central 3 degrees metamorphopsia (visual distortion) in patients with maculopathy, including agerelated macular degeneration and diabetic retinopathy, and as an aid in monitoring progression of disease factors causing metamorphopsia. It is intended to be used by patients who have the capability to regularly perform a simple self-test at home. The myVisionTrackTM is not intended to diagnose; diagnosis is the responsibility of the prescribing eye-care professional.
Device Description
The myVisionTrack™ is a vision function test provided on a commercially available cell phone. The myVisionTrack™ implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. This enables regular monitoring of disease progression, and for timely detection of significant changes in vision function. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
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