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Topcon Medical Systems, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Topcon Medical Systems, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-11-20FDA-DeviceClass IIThe IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection, storage and management of digital images, patient data, diagnostic data and clinical information from Topcon devices. It is intended for processing and displaying ophthalmic images and optical coherence tomography data. The IMAGEnet 6 Ophthalmic Data System uses the same algorithms and reference databases from the original data capture device as a quantitative tool for the comparison of pos
The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called "Hood Report", is not appropriate as it can imply a structure/function correlation for which clinical evidence is not provided
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