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TOPCON MEDICAL SYSTEMS INC

IMAGENET · Gastroenterology and Urology

510(k): 1 Recall: 2 UDI: 0 MAUDE: 0 Class.: 0

510(k) Clearances (1)

IMAGENET 5 PC SOFTWARE SYSTEM
2013-10-17

Substantially Equivalent

Recalls (2)

The 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 coh
2024-09-17

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

IMAGEnet 6 v1.53- 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 without controlling or altering the functions and parameters of
2019-03-06

When a patient is selected in the patient data and another patient is selected prior to the display of the primary patient's thumbnails is completed, then the primary patient's thumbnails are displayed with secondary patient's identification information such as name, patient's ID, etc. on the monitor screen of the PC used.