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510(k) Data Aggregation

    K Number
    K003325
    Device Name
    KSI'S NEW CAMERA ARCHITECTURE (NCA) VIDEO IMAGING SYSTEM
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    2001-04-27

    (185 days)

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

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope and the endoscopic image can be displayed on any standard operating room video monitor. All standard endoscopic light sources may be used with New Camera Architecture (NCA) camera heads. The camera heads will be available in NTSC and PAL configurations.
    Device Description
    The Karl Storz Imaging (KSI) New Camera Architecture (NCA) Video Imaging System is a color, television camera system intended for use with rigid or flexible endoscopes.
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    K Number
    K001362
    Device Name
    KARL STORZ 3D VIDEO SYSTEM
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    2000-07-17

    (80 days)

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

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K994090
    Device Name
    KARL STORZ AUTOCLAVABLE CAMERA HEAD
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    2000-02-04

    (63 days)

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

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.
    Device Description
    The new autoclavable camera heads are identical to previous single chip and three chip models with the exception that these units are hermetically sealed and use a magnetic switch for operating the integral hand-held camera controls.
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    K Number
    K990154
    Device Name
    KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    1999-06-01

    (133 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Imaging (KSI) Direct Coupled Interface (DCI 5) Camera System combines a color, television camera head with an integrated light source cable and camera control unit (CCU). These units are designed for attachment to any Karl Storz Tuttlingen (KST) DCI compatible rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The DCI 5 camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the camera head until it locks into place. An optional adapter allows DCI 5 camera head attachment to non-DCI rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor. All commonly available endoscopic light sources may be used with the DCI 5 System.
    Device Description
    The KSI DCI 5 incorporates two programmable function buttons (to select an accessory port(s) and to control the port output), a focus knob and a zoom in/zoom out control bar. The camera head also has an integrated light cable. The camera is designed to allow the user to axially rotate the camera head while maintaining proper image orientation on the monitor.
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    K Number
    K974391
    Device Name
    KARL STORZ ENDOVISION XL ENDOSCOPIC CAMERA SYSTEM
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    1998-01-30

    (70 days)

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

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Imaging (KSI) Endovision XL System is a color, television camera head designed for use with any flexible or rigid endoscope. The camera head may be attached to any rigid or flexible endoscope, such as sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera is connected to the video processor via a ten foot cable. The endoscopic image can be displayed on any standard operating room video monitor.
    Device Description
    The Endovision XL is a state-of-the-art endoscopic camera. The head of the camera is equipped with a V-mount thread, allowing the head to couple to Karl Storz V-mount optical adapters. Three adapters, 15 mm, 20 mm and 25 mm, are available with the system. These couplers allow easy attachment of the XL head to any standard endoscope. Microprocessor controlled automatic exposure adjusts image brightness. The image sensor is a 1/4" CCD-chip. The processor weighs 1.77 pounds and the camera .6 pounds. Dimensions of the processor and camera in width, height and depth are: 8.29 x 2.16 x 6.07 inches and 1.96 x 2.4 x 3.9 inches respectively.
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    K Number
    K973252
    Device Name
    KARL STORZ DIRECT COUPLED CAMERA HEAD
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    1997-11-24

    (87 days)

    Product Code
    FET, 78K
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Karl Storz Imaging (KSI) Direct Coupled (DCC) Camera Head is a color, television camera head designed for attachment to a Karl Storz Tuttlingen (KST) DCC endoscopic visioning system. The KSI DCC camera head is compatible with the currently marketed KSI Telecam SL (Super Luxury) video processor and the KSI Telecam SL with IPM (Image Processing Module) video processor. The camera head is suitable for attachment to any KST DCC rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope by directly pressing the endoscope onto the front of the DCC camera head until it locks into place. An optional adapter allows DCC camera head attachment to non-DCC rigid and flexible endoscopes. The endoscopic image can be displayed on any standard operating room video monitor.
    Device Description
    The KSI DCC incorporates two programmable function buttons (to select an accessory port(s) and to control the port output) and two focus buttons. The light cable is connected directly to the back of the camera head. The camera is designed to allow the user to directionally rotate the camera head to maintain proper image orientation on the monitor.
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    K Number
    K963333
    Device Name
    OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340)
    Manufacturer
    KARL STORZ IMAGING, INC.
    Date Cleared
    1996-10-22

    (60 days)

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

    KARL STORZ IMAGING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optronics EPIC System is intended for use as an accessory to a slit lamp biomicroscope, providing enhanced imaging of the eye for opthalmic examination, diagnosis, treatment definition and clarification, and patient education/proof of treatment need
    Device Description
    The Optronics EPIC System consists of a camera and a video processor. The camera consists of a camera head with eyepiece and beamsplitter and an integral cable for electronic transmission of signals and power. The camera head consists of an outer aluminum shell housing the video sensor and optical elements. The cable is permanently attached to the camera head and connects to the processor. The processor consists of a finished aluminum housing containing the power supply, circuit boards, and interconnections necessary to process the video image.
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