FDA-Device2019-04-24Class II
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 any medical devices or through computerized networks.
Topcon Medical Systems, Inc.
Hazard
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.
Sold states
Nationwide
Affected count
450 units
Manufactured in
111 Bauer Dr, N/A, Oakland, NJ, United States
Products
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 any medical devices or through computerized networks.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1138-2019Don't want to check this manually?
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