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510(k) Data Aggregation

    K Number
    K053412
    Device Name
    FLEXISCOPE, MODELS 50MH AND 50 MHC
    Manufacturer
    SCHOELLY IMAGING, INC.
    Date Cleared
    2006-02-23

    (78 days)

    Product Code
    FWF, GCT
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FlexiScope 50MH / 50MHC is indicated for use in conjunction with endoscopic devices to provide illumination and video visualization of optical images.
    Device Description
    The Schoelly FlexiScope 50MH / 50MHC system is comprised of a camera handpiece and a combination light source / video processor; the system is intended for use with currently marketed endoscopes. The light source utilizes visible light to provide illumination of the area under endoscopic examination. The compact camera system component attaches to the proximal eyepiece of the user-supplied flexible or rigid endoscope. Images are optically captured via the endoscope. The image is transferred to the camera's CCD (charge coupled device) sensor through the scope objective lens, where it is converted to an electrical signal and amplified for output to accessories such as a monitor, printer, etc.
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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?
    Product Code :

    FWF

    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
    K982754
    Device Name
    EC-1000-7 DIGITAL ENDOSCOPY VIDEO CAMERA, MODELS EC 1000-7P (PAL) & EC 1000-7N (NTSC)
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-01-08

    (155 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EC 1000-7 Digital Endoscopy Video Camera is a device used for monitoring and recording during endoscopic procedures.
    Device Description
    EC 1000-7 Digital Endoscopy Video Camera (Models EC 1000-7P (PAL) & EC 1000-7 (NTSC))
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    K Number
    K982965
    Device Name
    ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES
    Manufacturer
    RICHARD WOLF MEDICAL INSTRUMENTS CORP.
    Date Cleared
    1998-11-23

    (90 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions. The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.
    Device Description
    The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller. The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.
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    K Number
    K982397
    Device Name
    VES 3001-M COMPLETE VIDEO ENDOSCOPIC SYSTEM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-09-10

    (63 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 3001-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
    Device Description
    Not Found
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    K Number
    K982409
    Device Name
    VES 1501-M
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-08-21

    (42 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES 1501-m use is indicated whenever video display from an endoscope is required for more convenient viewing.
    Device Description
    Not Found
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    K Number
    K981819
    Device Name
    ANGIOLAZ VES-1CAM
    Manufacturer
    ANGIOLAZ, INC.
    Date Cleared
    1998-08-04

    (74 days)

    Product Code
    FWF
    Regulation Number
    878.4160
    Why did this record match?
    Product Code :

    FWF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VES-1CAM use is indicated when ever there is a need for the use of video in endoscopic procedure.
    Device Description
    Not Found
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