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510(k) Data Aggregation

    K Number
    K232143
    Device Name
    Applanation Tonometer HT-5000
    Manufacturer
    Huvitz Co., Ltd.
    Date Cleared
    2023-10-23

    (96 days)

    Product Code
    HKY
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    Huvitz Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Applanation Tonometer HT-5000 is a manual device intended to measure an intraocular pressure by applanation to aid in the diagnosis of glaucoma. The Applanation Tonometer HT-5000 is indicated for measurement of intraocular pressure (IOP). Intraocular pressure (IOP) is a very important physiological parameter and has always been an indispensable part of the diagnosis and treatment of ophthalmology, especially for glaucoma.
    Device Description
    The Applanation Tonometer HT-5000 is an active medical device, powered by AAA batteries. The device can be used in conjunction with slit lamp microscopes which are commercially available. Components of the tonometer contains applanation tonometer main body, weight bars, connection arms and measuring prisms.
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    K Number
    K202097
    Device Name
    Fundus Camera
    Manufacturer
    Huvitz Co., Ltd.
    Date Cleared
    2021-02-02

    (188 days)

    Product Code
    HKI
    Regulation Number
    886.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    Huvitz Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HFC-1 fundus camera is intended to capture digital images for the anterior and retina segment of the eye without the use of a mydriatic agent. It is intended for use as an aid to clinicians in the evaluation and diagnosis of ocular health.
    Device Description
    HFC-1 Fundus Camera captures, store and display color fundus images with built-in 20 Mega pixel colored channel up to 45-degree field of view. HFC-1 Fundus Camera is designed as a non-contact, non-invasive and high resolution digital imaging device. HFC-1 Fundus Camera has a retinal imaging system that provides digital images of the eyes to assist physicians in diagnostic examinations. The anterior of an eye is illuminated by IR light, the retina of an eye is illuminated by a white LED, emitted by the fundus illumination optical system. The fundus observation/photography optical system obtains an image with image sensors and images are observed and manipulated on the display panel.
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    K Number
    K191615
    Device Name
    Huvitz Imaging System
    Manufacturer
    Huvitz Co., Ltd.
    Date Cleared
    2019-07-18

    (30 days)

    Product Code
    NFJ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Huvitz Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.
    Device Description
    Huvitz Imaging System (HIS-5000U) consists of slit lamp camera (HIS-5000U(10.0M), HIS-5000U(5.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N). It is a digital imaging system with a high resolution digital camera and PC based patient diagnostic data management software intended for controlling digital imaging devices, acceptance, transfer, display, storage and digital processing of ophthalmic images including videos, acquired from a of a slit lamp camera through direct connection or network. The imaging software (HIS-5000N) supports networking function to share patient information and examination images between multiple PCs existing on the local network or internet via TCP/IP protocol. Also, this version uses MS-SQL server solution as more reliable database, and includes additional HIS Server Management software to support to back up or restore patient and imaging data. HIS-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings.
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    K Number
    K161829
    Device Name
    Huvitz Imaging System
    Manufacturer
    HUVITZ CO., LTD.
    Date Cleared
    2017-04-06

    (275 days)

    Product Code
    NFJ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUVITZ CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Huvitz Imaging system (HIS-5000U) is intended for controlling digital imaging devices and for acceptance, transfer, display, storage and digital processing of documentation ophthalmic images and videos, acquired from a slit lamp camera through a direct connection to a PC or to multiple PCs via a local network.
    Device Description
    Huvitz Imaging System (HIS-5000U) consists of slit lamp camera (HIS-5000L (10.0M), HIS-5000U(1.4M)), Communication Cable and Imaging Software (HIS-5000N). It is a digital imaging system with a high resolution digital camera and PC based patient diagnostic data management software intended for controlling digital imaging devices, acceptance, transfer, display, storage and digital processing of ophthalmic images including videos, acquired from a of a slit lamp camera through direct connection or network. The imaging software (HIS-5000N) supports networking function to share patient information and examination images between multiple PCs existing on the local network or internet via TCP/IP protocol. Also, this version uses MS-SQL server solution as more reliable database, and includes additional HIS Server Management software to support to back up or restore patient and imaging data. HIS-5000N imaging system software is not able and intended to provide any diagnosis but help the user to view the visible structures of the eye and store the findings.
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    K Number
    K093639
    Device Name
    SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500
    Manufacturer
    HUVITZ CO., LTD.
    Date Cleared
    2009-12-03

    (9 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUVITZ CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Slit Lamps HS-5500, HS-7000, HS-7500 are intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
    Device Description
    A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, form the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific diagnostic procedures (bio-microscopic examination of the eye). The instrument is consist of a microscope, a swiveling illumination system providing a slit image and a power supply.
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    K Number
    K073190
    Device Name
    SLIT LAMP
    Manufacturer
    HUVITZ CO., LTD.
    Date Cleared
    2008-01-11

    (59 days)

    Product Code
    HJO
    Regulation Number
    886.1850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUVITZ CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SLIT LAMP, HS-5000 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.
    Device Description
    A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific procedures (biomicroscopic examination of the eye). The instrument is consist of a microscope, a swivelling illumination system providing a slit image and a power supply. AC Power is converted to DC Power through the SMPS. DC Power is supplied to the Lamp providing the light. Light is converted to the slit image through the aperture, filter etc. The slit image is illuminate the eye. Observe the eye through the microscope.
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