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Sources: EU EUDAMED, US FDA
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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 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 posterior ocular measurements to a database of known normal subjects.
FDA Enforcement
Class II
·Ongoing·Topcon Medical Systems, Inc.·November 20, 2024
Harmony Referral System (aka Harmony RS)/ Medical Device Data System - Product Usage: intended to be used by trained healthcare professionals and clinicians to access archived multimedia data, forms and patient information.
FDA Enforcement
Class II
·Terminated·Topcon Medical Systems, Inc.·February 10, 2021
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.
FDA Enforcement
Class II
·Terminated·Topcon Medical Systems, Inc.·April 24, 2019
Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.
FDA Enforcement
Class II
·Terminated·Topcon Medical Laser Systems, Inc·August 17, 2016
PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
FDA Enforcement
Class II
·Terminated·Topcon Medical Laser Systems, Inc·July 31, 2013