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510(k) Data Aggregation

    K Number
    K042885
    Device Name
    OCT-OPTHALMOSCOPE
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    2005-01-21

    (94 days)

    Product Code
    HLI, OBO
    Regulation Number
    886.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI OCT Ophthalmoscope is intended to offer simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. It is indicated in situations where these images are required for diagnosis.
    Device Description
    The OTI OCT Ophthalmoscope produces simultaneous acquisition of highresolution transversal OCT (Optical Coherence Tomography) and confocal images of the eye fundus. In addition conventional longitudinal OCT images may also be collected. The system uses a high power superluminescient diode operating at 850nm. The software uses a tabbed interface: the user can select any of the primary functional modules at any time by clicking on the tab for that function at the top of the screen. When there are several major components in a function, these are presented as tabs below the principal tab bar.
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    K Number
    K031391
    Device Name
    HF MODULE WITH TRANSDUCERS
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    2003-06-20

    (49 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Transducer for B-scans with OTI-Scan HF Module Mode of Operation Ophthalmic
    Device Description
    The OTI-scan HF module is an ultrasonic ophthalmic B-scan system that uses the principles of sonar (pulsed ultrasound) to visualize and measure the interior of the eye with high-frequency transducers to obtain better accuracy.
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    K Number
    K030770
    Device Name
    OTI SCAN WITH TRANSDUCERS
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    2003-03-27

    (16 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI-scan ultrasound system is a multi-purpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
    Device Description
    The OTI-scan is a compact Ultrasonic ophthalmic A-scan system and B-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes and to visualize the interior of the eye.
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    K Number
    K024114
    Device Name
    A-SCAN 100
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    2003-01-10

    (28 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The A-scan 100 is an ophthalmic A-scan system intended to be used for measurement of axial distances in the eye and for the calculation of the power of an implanted intraocular lens (IOL), indicated for patients requiring intraocular lenses.
    Device Description
    The A-scan 100 is a compact device Ultrasonic ophthalmic A-scan system that uses the principles of sonar (pulsed ultrasound) to measure the axial length of the eyes. The device includes four popular formulas to calculate the implanted IOL power, using the Ultrasound Axial Length measurement. The results may be printed through a PC computer printers.
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    K Number
    K990064
    Device Name
    DI-RHEX OPHTHALMIC DIATHERMY SYSTEM
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    1999-04-04

    (86 days)

    Product Code
    HQR
    Regulation Number
    886.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI Di-thex Ophthalmic Diathermy Unit is intended to be used for producing haemeostasis in the anterior and posterior segment of the eye, for conjunctival welding (coaptation), retinal coagulation using endodiathermy tips, and for cutting in ophthalmic surgery, using a high frequency current applied by a bipolar probe.
    Device Description
    The system consists of a central control unit that supplies radio frequency energy to a handpiece. The unit can be used for standard diathermy procedures, and can be also used as a cutting instrument for membrane dissection in the eye with the appropriate handpieces and tips. Power level is microprocessor-controlled, and the power-level setting is shown by a bar-graph display on the front panel. The system has a set of alarms which alert the user and suspend operation for such cases as overtemperature, overvoltage, and computer errors.
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    K Number
    K974522
    Device Name
    3D I-SCAN
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    1998-02-25

    (85 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ophthalmic Technologies Inc. (OTI) 3D i-scan is intended to be used as an accessory with the OTI i-scan Ophthalmic B-scan Ultrasound system (K960622) to provide a three-dimensional visualization of the interior of the globe. The device is indicated when it is desirable to have a three-dimensional depiction (perspective rendering) of the interior of the globe for diagnostic purposes.
    Device Description
    The 3D i-scan works in conjunction with the Ophthalmic Technologies Inc. (OTI) i-scan ophthalmic B-scan system. It automatically makes a series of 201 B-scans at different angles, and then combines them to produce a perspective image, called the "3D image." Scanning is done through a closed eye-lid. The 3D i-scan consists of a computer and computer monitor, and a mechanical scan assembly which holds the B-scan ultrasonic scanner and rotates it at a speed synchronized with the lateral scanning rate of the probe. Ultrasonic gel is used as a coupling medium between the transducer and the surface of the eye-lid. The computer system assembles the multiple images of the interior of the eye, all taken at a slightly different angle, and produces a three-dimensional representation of the interior of the eye on the computer monitor screen. Software facilities are included for a number of types of image manipulation, such as slicing, changing perspective or line, and measurement of distances, areas, and volumes.
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    K Number
    K971679
    Device Name
    I-SCOPE OPHTHALMIC ENDOSCOPE
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    1997-06-25

    (49 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ophthalmic Technologies i-Scope™ is intended to be used for visualization of intra-ocular structures, as a means to introduce micro instruments into the eye, or as a means to introduce laser fibers into the eye for photocoagulation.
    Device Description
    The Ophthalmic Technologies i-Scope™ is a rigid ophthalmic fiber-optic microendoscope. The i-Scope has an imaging fiber bundle with 10,000 pixels, an illumination fiber, and a working channel for an optional laser fiber or microinstruments. The laser fiber is disposable and can be replaced between cases. The fiber is not manufactured by Ophthalmic Technologies. The image fiber bundle terminal is connected to an orientation ring, video adapter and video camera. The illuminating bundle fiber can be connected to the OTI "XE-LITE" Xenon Light Source, or other light sources which have been cleared by the FDA. The laser fiber is disposable and can be replaced between cases.
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    K Number
    K960622
    Device Name
    I-SCAN
    Manufacturer
    OPHTHALMIC TECHNOLOGIES, INC.
    Date Cleared
    1996-05-13

    (90 days)

    Product Code
    IYO
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    OPHTHALMIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OTI i+tech "i-scan" ultrasound system is intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL power.
    Device Description
    The OTI i+tech "i-scan" ultrasound system is a multipurpose personal-computer-based ultrasonic diagnosis system for ophthalmic applications. It includes three separate transducers which provide: 1. A Biometry X-mode for measurement of axial length, using a focused probe which can be hand-held or placed in a tonometer-holder. The operator has a choice of automatic measurement (in which the system automatically finds the critical structures in the eye and makes the measurements) or manual (in which the A-scan is presented on screen and the operator selects the points for a the measurements). 2. An A-scan mode for observation and measurement of the internal structures in the eye, with its own handheld probe. 3. A B-scan mode, usinç a hand-held motor-driven transducer, permitting visualization of internal structures in the eye. In X-mode, the system also performs IOL calculations with a choice of several algorithms.
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