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510(k) Data Aggregation

    K Number
    K021236
    Device Name
    SURGERY AND ACCESSORIES
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    2002-07-17

    (90 days)

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

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures.
    Device Description
    The Surgery Image Recorder (SIR) is an acquisition unit for digitizing and storing images generated during surgical proceedings that are typically related to, but not limited to, endoscopic surgery procedures. The SIR is designed to provide surgeons the ability to capture still images and streaming video from standard video outputs typically associated with imaging devices used during endoscopic surgery. To allow for the entry of patient demographic information and to provide a user interface the SIR will have and VO for a USB type keyboard and mouse, and will also provide I/O's for a USB compatible color printer, video outputs, serial outputs and network connectivity. Additionally, the SIR will be able to store data to its internal hard disk drive and to removable storage media (e.g., DVD, CD-R).
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    K Number
    K013032
    Device Name
    PHYSIOLOG, SERIES 95000
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    2002-06-04

    (267 days)

    Product Code
    DQK, DOK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.
    Device Description
    VERICIS Physiolog monitors, measures, and/or records physiologic data and patient images from a patient undergoing a cardiac catheterization procedure. VERICIS Physiolog is intended for use in hospital cardiac catheterization laboratories.
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    K Number
    K992666
    Device Name
    VIDEO PLUS SYSTEM, SERIES 95000
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    1999-10-13

    (65 days)

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

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Video Plus is a digital imaging acquisition and review system for the cardiac video Fras is a cigation findedigital fluoroscopy, digital fluoroscopy, digital cine, real time cannoterization no. To icatalor meterssing, image processing, quantitative coronary processing digital subtraction angiography, digital video input, linked biplane acquisition, auto injection, and histogram equalization.
    Device Description
    This is a software upgrade for the existing Video Plus System cleared under K954159. This release encompasses some general enhancements and more integrated support for certain vendors.
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    K Number
    K992259
    Device Name
    ECHOCARDIOGRAPHY SYSTEM SERIES 95000
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    1999-09-08

    (64 days)

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

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A digital image capture, storage, and review system for echocardiography.
    Device Description
    The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
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    K Number
    K990066
    Device Name
    CCD CAMERA, MODEL 9000
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    1999-03-17

    (68 days)

    Product Code
    LMA
    Regulation Number
    892.2030
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
    Device Description
    This device is a Charge Coupled Device (CCD) video camera for use in digital radiography, including DSA, high resolution cardiology, and low dose fluoroscopy. It is designed for use with X-ray image intensifiers in diagnostic imaging chains.
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    K Number
    K955519
    Device Name
    ANALYTICAL REVIEW STATION
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    1996-05-09

    (157 days)

    Product Code
    IZI
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.
    Device Description
    Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.
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    K Number
    K954159
    Device Name
    DIGITAL IMAGING SYSTEM
    Manufacturer
    CAMTRONICS, LTD.
    Date Cleared
    1996-03-19

    (196 days)

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

    CAMTRONICS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Image Acquisition . - . Display Control/Image Processing - Input /Output Control . - . Patient Data Management
    Device Description
    Digital image recording and display system fo use in a cardiac catheterization laboratory or radiography/fluoroscopy suite.
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