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Found 18 results
510(k) Data Aggregation
K Number
K232406Device Name
KARL STORZ OR1 SCB CONTROL (WU300)
Manufacturer
Karl Storz SE & Co. KG
Date Cleared
2023-10-03
(54 days)
Product Code
ODA, FET
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ OR1™ SCB CONTROL provides central control of compatible medical equipment in the operating room during diagnostic and therapeutic procedures.
Device Description
The KARL STORZ OR1™ SCB CONTROL is a central control unit which provides a single point of contact in the operating room for centralized control of various medical devices in sterile and non-sterile areas during diagnostic and therapeutic procedures. The system consists of KARL STORZ OR1™ SCB CONTROL software run on a dedicated KARL STORZ OR1™ SCB CONTROL hardware platform (Model Number: WU300) which connects to a touch-sensitive LCD monitor (Model Number: WM100 or WM101).
The user interface enables central display and control of multiple parameters for KARL STORZ and third-party devices connected via SCB serial cable or ethernet cable to the KARL STORZ OR1™ SCB CONTROL hardware CPU. The equipment controls can be operated via sterile input on the touchscreen monitor with the use of a sterile disposable cover. Outside the sterile area a keyboard or mouse can optionally be used.
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K Number
K221929Device Name
Smith+Nephew INTELLIO Tablet
Manufacturer
Smith+Nephew
Date Cleared
2022-09-06
(67 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smith+Nephew INTELLIO Tablet is indicated for use to provide wired or wireless remote control of Smith+Nephew compatible surgical and endoscopic devices within the operating room including camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
Device Description
The INTELLIO Tablet application software is pre-installed upon a medical grade tablet that is used with compatible Smith + Nephew surgical and endoscopic device allows for control of parameters within the operating room, including camera control system, patient information system, mechanical resection system, Fluid Management system and RF Coblation system. The device also connects to the MY.INTELLIO™ cloud and provides access to medical device status, settings, images/videos, and reports before, during and after surgical procedures. Additionally, software updates are manually downloaded from the MY.INTELLIO cloud account via secured link and can be installed via the administrator account. The device is able to set parameters remotely for the Fluid management pumps, Mechanical Resection controller and RF Coblation controller by connecting to the Wifi connect device either separate (LINK box) or integrated with the individual pump or controller. It also provides a secondary control mechanism for all of these devices forming a connected system. The primary control for setting parameters are on the individual devices.
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K Number
K203566Device Name
Tablet Application
Manufacturer
Smith & Nephew
Date Cleared
2021-05-13
(157 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of Smith & Nephew compatible surgical and endoscopic devices within the operating room including camera/camera control unit, patient information system, mechanical resection system, fluid management system and RF coblation system. These controls consist of adjusting parameter settings only.
Device Description
The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
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K Number
K192876Device Name
INTELLIO Tablet Application
Manufacturer
Smith & Nephew
Date Cleared
2020-02-27
(142 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Smith & Nephew Tablet Application is indicated for use to provide wireless control of parameters settings for compatible Smith & Nephew surgical and endoscopic devices within the operating room including cameralcamera control unit, patient information system, DYONICS POWER II Control Unit and the Werewolf Controller.
Device Description
The Smith & Nephew Tablet Application is a software application that provides a Wi-Fi connection between compatible medical devices. Once connected the Tablet Application has the ability to provide limited remote control to the connected devices.
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K Number
K153205Device Name
IDSS ForceTriad Control Module
Manufacturer
BLACK DIAMOND VIDEO, INC
Date Cleared
2016-08-01
(271 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IDSS-ForceTriad Control Module is designed for integration in the IDSS(Integrated Digital Surgical Suite) and enables the Covidien ForceTriad Energy Platform to be controlled remotely.
Device Description
The IDSS ForceTriad Control Module is an additional function to the IDSS, which is an integrated operating room system controlling video displays, observation cameras, audio video equipment, teleconferencing and the routing of video and images from multiple sources to multiple destinations via a touch screen interface. With the IDSS ForceTriad Control Module, operation room staff is able to control the ForceTriad setup from the touch panel location rather than using the ForceTriad unit itself.
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K Number
K151282Device Name
core nova Complete Operating Room Endoscopy
Manufacturer
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Date Cleared
2016-01-12
(243 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Core.nova (core.browser, core.connect with driver, IR Transceiver, core.media, and core.portal) are components used for the central control of integrated medical devices and accessories in one central location within the operating room. In particular core.nova is used for the control of connected compatible OR equipment, like OR-lamp, OR-camera, ORtable, insufflator, or video- and documentation system intended for diagnostic and therapeutic medical conditions. The connected devices (Richard Wolf or third party) can be control terminals (with touch screen), or the control mechanism on actual device.
Device Description
The core nova (complete operating room endoscopy nova) by Richard Wolf is a networkbased integrated operating room accessory that provides central control to various Richard Wolf devices and third party devices. This control allows the user to control device settings from the sterile area. Richard Wolf's core nova is comprised of core.browser, core.connect with driver, IR Transceiver, an optional core.media, and an optional server core.portal.
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K Number
K111165Device Name
KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2012-01-06
(255 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KARL STORZ SCB/Covidien ForceTriad Interface Module is designed for integration in the SCB Interface Control, SCB Media Control or ACC Control and enables the COVIDIEN ForceTriad Energy Platform to be controlled remotely with the KARL STORZ SCB control NEO system.
Device Description
The Karl Storz SCB/Covidien ForceTriad Interface Module is an accessory to integrate the third party device Covidien ForceTriad Energy Platform (K102913) into the SCB network and allow remote settings adjustment.
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K Number
K102763Device Name
SYSTEMS INTEGRATION
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORPORATION
Date Cleared
2011-02-15
(144 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SYSTEMS INTEGRATION ENDOALPHA (MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-3) Software Version 2
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
UPGRADE KIT FOR UCES-3 (Version 2) MAJ-1943
This equipment has been designed to install software on the ENDOALPHA UCES-3, MAJ-1831, MAJ-1832, MAJ-1834, and MAJ-1862.
Device Description
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
1) Centralized control from a non-sterilized area
2) Centralized control from a sterilized area
3) Centralized display
4) Message display
5) Voice reply
6) Automatic settings
7) Scene settings
8) Display customization
9) Still image viewing
10) Automatic smoke evacuation
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K Number
K100345Device Name
SYSTEMS INTEGRATION MODEL: ENDOALPHA
Manufacturer
OLYMPUS MEDICAL SYSTEMS CORPORATION
Date Cleared
2010-03-22
(45 days)
Product Code
ODA, GCJ
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Systems Integration ENDOALPHA has been designed to be used with an Olympus endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
Device Description
The Systems Integration ENDOALPHA has been designed to be used with an Olymous endoscope and ancillary equipment for central operation, central display, automatic initial setting, and interlocking operation of the ancillary equipment.
The ENDOALPHA integrated electrosurgical system has the following system functions.
1) Centralized control from a non-sterilized area
2} Centralized control from a sterilized area
3) Centralized display
4) Message display
5) Voice reply .
6) Automatic settings
7) Scene settings
8) Display customization
9) Still image viewing
10) Automatic smoke evacuation
The modifications made to the subject device are as follows:
A) Addition or deletion of recommended ancillary equipment
B) A change involving the communication interface
C) A change in the design of the Graphical User interface (GUI)
D) Addition of a voice reply function
E) Deletion of Surgeon's controller for EndoALPHA (MAJ-1140)
F) Transfer of Input/Output function for video signals to the Advanced system
G) Addition of additional connectable touch panel
H) Addition of Scene settings function
l) Addition of system components
Changes to the specifications of system components S
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K Number
K083598Device Name
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
Manufacturer
KARL STORZ ENDOSCOPY-AMERICA, INC.
Date Cleared
2009-05-29
(175 days)
Product Code
ODA
Regulation Number
876.1500Why did this record match?
Product Code :
ODA
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Karl Storz VOICE1® SCB R-UI Speech Control Application is indicated for use in speech control of Karl Storz-approved devices and peripherals in conjunction with the Karl Storz SCB® R-UI software.
Device Description
The Karl Storz VOICE1® SCB R-UI Speech Control Application is an independent application that works in the background of the SCB R-UI. VOICE1® recognizes commands spoken by the user and sends corresponding commands to the SCB R-UI system, enabling the user to control endoscopic and other ancillary surgical equipment and adjust device parameters entirely by speech control.
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