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510(k) Data Aggregation

    K Number
    K140930
    Device Name
    VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES
    Manufacturer
    CONVIDA HEALTHCARE & SYSTEMS CORPORATION
    Date Cleared
    2014-06-09

    (59 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CONVIDA HEALTHCARE **& SYSTEMS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room.
    Device Description
    The VIDA LED Surgical Lighting System, V series provide illumination for surgery or examination at operating room. VIDA LED Surgical Lighting System, V series uses high-efficacy light-emitting-diodes (LED) as light source which provides high brightness and no extra heat; the design of the optical mechanism gives a characteristic of less shadow which is significant to the surgeon during the operation. Given of its modular design, VIDA V provided many options for configurations and can be installed in an operating room with or without a laminar air flow system. The features of VIDA LED Surgical Lighting System, V series are as followed: - Prism-Based Light Delivery Technology: ConVida's patented optical system, that . combines an advanced refractive prism lens and innovative high-power LED technology, focuses light into an intense 110cm (43") focal cylinder, eliminating the need for refocusing when adjusting surgical table. - . Consistent Illumination at Different Color Temperature Settings: VIDA V series lighthead's color temperature can be individually adjusted at any of the 5 settings (3500K, 4000K, 4250K, 4500K, 5000K) with a high CRI of 95, R9 94. - . Optimal Brightness without Glare: Elegant, sophisticated optical system consists up to 2 types of high-power LEDs and multiple refractive prisms produces up to 160,000 lux of intensity without discomfort flare/glare. - . VIDA V light gives the Surgeon Control: On the VIDA V, both lighthead focus and light intensity can easily be adjusted via turning the lighthead handle. They are also adjustable from the standard lighthead control or optional VIDA V Control Center on the wall. - Long Lifetime: Under normal use, VIDA V LEDs enjoy an extremely long lifetime of . 50,000+ hours (70% lumen maintenance at 50,000 hours). - . Two Types of Ambient Lights (Option): 5% central luminance (GUIDE lighting mode) c be configured through standard lighthead control. Guide lighting mode may ambient lighting for manipulating endoscopy instruments or lighting diagnos procedures. Green ambient light sheds low-level green light from the suspension hub - Camera-Ready Lighthead is Built into the System: All VIDA V lightheads are pre-wired . with HD cabling for taking an optional HD 1080p Camera Handle. The HD 1080p Camera Handle is removable from one VIDA V lighthead to another providing superb flexibility for recording. - Exceptional Maneuvering Flexibility: The exceptionally durable non-sterile handles allow easy positioning of all our lightheads. Each lighthead rotates a full 360°so that the system can be quickly and easily positioned for any surgical procedure. Individual lightheads can be lower to 810mm above the floor providing excellent low lateral illumination. - . Sleek Non-Sterile Handle: The lighthead has is molded with a sleek all-around handle that facilitates easy repositioning and adds modern elegance to O.R. setting - Easy-to-clean Compact Lighthead: Made of tough molded materials, the VIDA V series . lightheads are completely sealed which helps prevent biocontaminants from entering the operative site and lighthead itself, and facilitates cleaning. - . HD Supported Suspensions: All VIDA V suspensions are prewired with video cables to deliver information users need within and without the surgical field. Images are in crisp and accurate HD format with no signal conversion necessary and no loss of video quality. - Heavy Duty HD Flat Monitor Suspension: Flat Monitor Suspension Arms support single/dual monitors up to a total of 24 kg (53 lbs), making them ideal for surgical displays up to 32". Large display compatibility allows the surgical team to see more of the procedural area. Optional Medical Grade LCD Displays from SONY also offer uncompressed HD video at 1080p which shows true images from SD- and HD-endoscopes, ultrasound, C-arms and other equipment. - Optimal HD Connectivity: The built-in fiber optic cable allows the suspension to support monitors featuring Full HD 1920 x 1080 video signals. - . Low Profile Suspension: Low-profile cardinal lighthead suspension is offered for rooms with ceiling lower than 280mm. - . Failsafe Design: The unit is protected against an electrical power failure, thus ensuring that all surgical procedures can continue without interruption.
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    K Number
    K132307
    Device Name
    VIDA LED SURGICAL LIGHTING SYSTEM
    Manufacturer
    CONVIDA HEALTHCARE & SYSTEMS CORPORATION
    Date Cleared
    2013-11-05

    (104 days)

    Product Code
    FSY
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    **CONVIDA HEALTHCARE **& SYSTEMS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VIDA LED Surgical Lighting System - X series provide illumination for surgery or examination at operating room.
    Device Description
    The VIDA LED Surgical Lighting System-X series provide illumination for surgery or examination at operating room. The VIDA LED Surgical Lighting System-X series (VIDA X) use high-efficacy light-emitting diodes (LED) for surgical operations and diagnostic purposes. LEDs provide bright and shadow reduced light. Thanks to its modular design. VIDA X also offers many options for configurations and can be installed in operating rooms with or without laminar air flow systems. A lighthead to the main spindle can be rotated horizontally with 360°. the spring arms can be rotated horizontally with 360° and moved vertically with 45° downwards and 30° upwards. The VIDA LED Surgical Lighting System-X series consists of Mounting Module, Horizontal Arm module, Suspension Device Module, sterile handle cover and Optional Accessories.
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