BEUDAMED
    8 results · 59ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    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 Recall
    Terminated ·Topcon Medical Systems, Inc.·Product code NFJ·March 6, 2019

    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 Recall
    Terminated ·Topcon Medical Systems, Inc.·Product code NFJ·December 18, 2020

    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

    PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.

    FDA Recall
    Terminated ·Topcon Medical Laser Systems, Inc·Product code HQF·March 27, 2012

    Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally.

    FDA Recall
    Terminated ·Topcon Medical Laser Systems, Inc·Product code HQF·July 15, 2016

    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