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510(k) Data Aggregation
K Number
K063310Device Name
TRUEFIELD ANALYZER
Manufacturer
SEEING MACHINES LIMITED
Date Cleared
2007-08-02
(273 days)
Product Code
HPT
Regulation Number
886.1605Why did this record match?
Applicant Name (Manufacturer) :
SEEING MACHINES LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TrueField Analyzer is an automated perimeter used to aid in measurement of visual field abnormalities.
For the assessment of visual field abnormalities.
Device Description
The TrueField Analyzer is an automated perimeter that is used to aid in measurement of visual field abnormalities. It is an objective device that monitors involuntary responses in the patient's pupils to a series of multi-focal visual stimuli presented to the eyes. The system presents stimuli and monitors the pupil responses in both eyes independently and concurrently.
The device includes:
- a bilateral image display system for providing individual visual stimulus to the patient's eyes (both eyes are concurrently and independently stimulated)
- A pair of video cameras for monitoring the patient's pupils again concurrently and independently
- A personal computer equipped to run Windows XP Professional Service Pack 2 operating system.
- The TrueField Software system. The TrueField Software automatically manages the stimulus presentation and video data acquisition, ensuring synchronization between the display and video image acquisition; data analysis, storage and presentation of results for review.
The TrueField Analyzer uses a different fundamental technology to the predicate device. It combines standard multi-focal stimulus and analysis technology (as used in other perimetry devices, for example K003442, K983983) with computerized pupil monitoring (for example K920937) allowing the device to objectively measure the visual field map of a patient. In doing so it is substantially equivalent to the predicate device (K954167).
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