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510(k) Data Aggregation
K Number
K200954Device Name
Glaucoma Module
Manufacturer
Topcon Healthcare Solutions, Inc.
Date Cleared
2020-08-03
(116 days)
Product Code
NFJ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Topcon Healthcare Solutions, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Glaucoma Module is a software application intended for the management, display and analysis of visual field and optical coherence tomography data. It is intended as an aid to the detection and management of visual field defects and progression of visual field loss.
Device Description
The Glaucoma Module works as an optional module, integrated into the Harmony user interface, and interfacing to Harmony to access the relevant data and information. Harmony is a comprehensive software platform intended for use in importing, processing, measurement, analysis and storage of clinical images and videos of the eye, as well as for management of patient data, diagnostic data, clinical information, reports from ophthalmic diagnostic instruments through either a direct connection with the instruments or through computerized networks. Harmony was most recently cleared by FDA in K182376.
The Glaucoma Module is a fully interactive multi-modality software for clinicians to assess, diagnose and manage patients who are glaucoma suspects or have been diagnosed with glaucoma. The Glaucoma Module is an aid to detection and management of visual field and OCT data.
The Glaucoma Module displays key information for diagnosis and management using a wellorganized interface.
Glaucoma Module is integrated into the Harmony user interface that utilizes both OCT exam and Visual Field data in an interactive manner. It employs two main sections, the Hood Dashboard screen used to determine glaucoma suspects and the Glaucoma Trend screen which can be used to observe patient data over a larger period of time.
The Glaucoma Module does not include predictive interpretations of the correlation of structural and functional measures, two measures that are understood to be independent of each other.
The Glaucoma Module will work with the following medical devices:
- Topcon's Maestro. Maestro 2, and Triton Optical Coherence Tomography devices .
- Zeiss' Visual Field instruments HFA3 and HFA Iii
- Visual Field data from other manufacturers. (e.g. Oculus EasyField) through DICOM ● OPV data format.
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