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Found 14 results
510(k) Data Aggregation
K Number
K150532Device Name
Universal Light Handle Cover, Light Handle Cover
Manufacturer
Key Surgical, Inc.
Date Cleared
2015-09-22
(204 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K142386Device Name
Operating Room Light Handle Adapter
Manufacturer
Litex Manufacturing, Inc.
Date Cleared
2014-09-29
(33 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Light Handle Adapters are permanent replacements to the original OEM handle provided by the light manufacturer in the event that the customer wishes to use a disposable light handle cover. This will eliminate the cleaning and resterilizing of the original OEM reusable light handle. The customer will need to replace the original OEM handle, with the light handle adapter that Litex Manufacturing, Inc. will provide the facility, through the light companies and other distributors.
Device Description
The Litex Manufacturing, Inc. Light Handle Adapter is a permanent replacement for the light manufacture's OEM reusable handle and it is designed to be permanently attached to the surgical light.
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K Number
K133554Device Name
SURGICAL LIGHT HANDLE COVER
Manufacturer
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY
Date Cleared
2014-04-08
(140 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A device intended to be used as a disposable barrier for a surgical lighting system and which allows a surgical team member to manually adjust the lighting system. This is a single-use device
Device Description
The Surgical Light Handle Cover is a polycarbonate injection molded device shaped to fit a surgical light that has release buttons protruding from the surgical light handle. The Surgical Light Handle Cover has apertures located at the end of the device, proximal to the surgical light, which correspond to the release buttons on the surgical light handle. When the Surgical Light Handle Cover is attached to the light, the release buttons will interface with the apertures to secure the Surgical Light Handle Cover to the light handle.
The Surgical Light Handle Cover is hollow in the center, with transparent polycarbonate located near the distal end. The transparent end permits the use of a recording device, which may be mounted onto the surgical light. The transparent end allows light to pass through for the purpose of recording images, it does not provide image enhancement or magnification.
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K Number
K133413Device Name
IDSS SLC
Manufacturer
BLACK DIAMOND VIDEO
Date Cleared
2014-01-07
(61 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IDSS SLC allows the control of surgical lighting during a surgical procedure from the IDSS, which is a centralized interface for voice, video, audio, observational camera and teleconferencing for the operating room.
Device Description
IDSS SLC is an additional function of the IDSS, which is an integrated operating room system that controls video displays, observation cameras, audio video equipment, teleconferencing and the routing of videos and images from multiple sources to multiple destination via touch screen interface.
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K Number
K112133Device Name
OASYS SURGICAL LIGHT CONTROLLER
Manufacturer
OASYS HEALTHCARE
Date Cleared
2012-03-01
(219 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OASYS Surgical Light Controller Software allows the control of surgical lights during a procedure from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light.
Device Description
The OASYS Surgical Light Controller allows the control of surgical lights from the OASYS View user interface touch panel. It displays the status of the surgical light and controls the operation of the surgical light. It works with surgical lights from many vendors.
The OASYS Surgical Light Controller communicates with the target surgical light using serial or Ethernet communications. All communications include error and exception handling. The safety features and controls of the surgical light take precedence over these communications.
This software controlling the Surgical Light is written with C# and XML data structures that run on Windows Embedded 7. The software is an optional module to the OASYS View OR Control application. OASYS View is a medical control application that allows for simple and streamlined management of an operating room. The software allows users to:
- Enable video routing from any source device to any destination device
- Preview selected sources on-screen
- Adjust image settings for video sources
- Change picture-in-picture capabilities on supported displays
- Control camera settings including:
- Panning & tilting
- Zooming
- Focusing
- Presets
- Operate medical-grade video recorders
- Select and listen to audio from an iPod or external audio device
- Engage in video conference calls
The software communicates with the light over a serial connection (RS485). Parameters are passed over a socket. The software manages the send and receive buffers to ensure effective communications. Data transmission is verified through the use of checksums and status commands.
The software allows for the Surgical Light to be initialized at run time. Default settings, such as brightness, are initialised on the Surgical Light. During normal operation, commands are passed back and forth based upon operator interaction with the graphical user interface. There are no patient contacting components.
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K Number
K102791Device Name
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
Manufacturer
IMAGE STREAM MEDICAL, INC.
Date Cleared
2010-11-23
(57 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EasySuite™ Surgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite™ touch panel user interface.
Device Description
The EasySuite™ Surgical Light Control (ESLC) is an optional function in the EasySuite™, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room for management of audio systems, and for control of devices such as room lights. The ESLC function allows control of surgical lights from the EasySuite™ touch panel user interface.
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K Number
K081698Device Name
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
Manufacturer
IMAGE STREAM MEDICAL, INC.
Date Cleared
2008-07-30
(43 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MainStream® OR Surgical Light Control (MSLC) allows the control of surgical lights from the Mainstream® OR touch panel user interface. It does not perform calculations. It displays surgical light status on the MainStream® OR display and allows control of the surgical lights. The safety features and controls of the surgical light system take precedence over the MainStream® OR surgical light control.
MSLC is an optional function in the MainStream® OR integrated operating room system. (The MainStream® OR system includes a touch panel user interface for quick routing of surgical images to displays within the operating room and for convenient control of room video cameras, surgical cameras, ambient lighting, and surgical lights. MainStream® OR also includes an audio management system and a single point of entry for querying surgical charts and image archives.)
Device Description
The MainStream® OR Surgical Light Control (MSLC) is an optional function in the MainStream ® OR, which is an integrated operating room system for configurable communication of images from sources to displays within the operating room, for management of audio systems, and for control of devices such as room lights.
The MSLC function allows control of surgical lights from the MainStream® OR touch panel user interface.
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K Number
K053321Device Name
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
Manufacturer
XODUS MEDICAL, INC.
Date Cleared
2006-01-19
(50 days)
Product Code
FTA, MDM
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Light Handle Cover is a single use sterile product. Its intended use is as a cover for surgical light handles. It is to be placed over the light handle prior to the start of a surgical procedure to provide the nurse or surgeon with a sterile protective cover to enable them to move the light during the procedure without compromising the sterility of their hands. This product does not come in contact with the patient.
Device Description
The disposable Light Guard Light Handle Cover is made from a plastic material and is a single use item used to cover the handle of a surgical light. This device fits over the handle of a surgical light to provide a sterile barrier between sterile personnel and the non-sterile light handle.
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K Number
K051505Device Name
SCB/STERIS OR-LIGHT INTERFACE BOX
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2005-08-11
(65 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STERIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.
Device Description
The Karl Storz SCB/STERIS OR-Light Interface Box connects the Storz Communication Bus computer to the STERIS Harmony OR-Light Control System. It enables the SCB computer to display and control the Harmony's functions.
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K Number
K023704Device Name
KSEA SCB ACC CONTROL
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2003-01-30
(87 days)
Product Code
FTA
Regulation Number
878.4580Why did this record match?
Product Code :
FTA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KSEA SCB ACC Control provides remote control for overhead and surgical lights, cameras, video devices, telephones, air-conditioning and teleconference equipment in the operating room.
Device Description
The Karl Storz SCB ACC Control is an interface device to provide remote control via a touch screen panel.
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