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510(k) Data Aggregation

    K Number
    K082212
    Device Name
    SYRINGE WITH HANDI-FIL
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2009-01-22

    (169 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or salıne into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals
    Device Description
    The proposed device is a disposable, single-use syringe, used to deliver radiographic contrast media and/or salme into a patient's vascular system for the purpose of obtaming enhanced diagnostic images The Syringe with Handi-Fil is plastic and consists of the same components as the predicate device The configuration is equivalent to other syringes already marketed by Mallinckrodt The synnge is provided to the customer packaged and sterilized. This submission covers the following devices: 150 ml syringe with Handı-Fil, 200 ml syringe with Handı-Fil.
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    K Number
    K073592
    Device Name
    OPTISTAR ELITE INJECTION SYSTEM
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2008-05-07

    (139 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.
    Device Description
    The Optistar Elite is a delivery system designed to inject image enhancing MR contrast media and flushing solutions into the vascular system for the purpose of obtaining enhanced diagnostic images. The Optistar Elite consists of 4 main components and syringes, just like the predicate device: Power Head, Console, Power Control, and Power Supply. Syringes accommodated include Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), Mallinckrodt pre-filled saline syringes (50ml and 125 ml), and empty disposable 60 ml Mallinckrodt syringes.
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    K Number
    K063503
    Device Name
    OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2007-04-27

    (158 days)

    Product Code
    IZQ
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
    Device Description
    The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device: - Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe. - Power Supply- The power supply converts the line voltage to the working voltage for the power head and console (approximately 24-vdc). - Console Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer. - Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.
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    K Number
    K042744
    Device Name
    OPTIV ANTAGE DH POWER INJECTION SYSTEM
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2004-11-30

    (57 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
    Device Description
    The OptiVantage DH Injection System delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage is made up of the following major components: - Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe. - Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc). - Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer. - Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.
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    K Number
    K031339
    Device Name
    OPTIBOLUS
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2003-07-11

    (74 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.
    Device Description
    The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol. The major components of the system are: 1. Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack. 2. Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions. 3. Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses. 4. Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.
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    K Number
    K022116
    Device Name
    ELPH INJECTION SYSTEM
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    2002-07-26

    (25 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ELPH Injection System is a contrast delivery system which is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.
    Device Description
    The ELPH Injection System will deliver radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The ELPH is made up of the following major components: Power Head, Power Pack, Remote Console (Optional), Syringes.
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    K Number
    K984088
    Device Name
    OPTISTAR MR INJECTOR SYSTEM
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    1999-12-06

    (385 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.
    Device Description
    The Optistar MR is a contrast delivery system that is designed to inject image enhancing contrast media into the vascular system of a human during an MRI (Magnetic Resonance Imaging) procedure. The main components of the Optistar MR system are the console, power pack, and powerhead. The console resides in the control room of the MR suite, while the power pack and powerhead remain in the scanning room with the patient. The parameters of the injection, such as volume and flow rate are programmed by the operator using a touch screen on the console. The console is powered by AC line voltage at 110 Volts at 60 Hz. The console communicates with the 24 VDC powerpack which in turn supplies power and the injection parameters to the powerhead. The powerhead performs the injections by driving one or two lead screw rams. The rams push the plunger of a syringe, which expels fluid from the barrel of the syringe.
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    K Number
    K963071
    Device Name
    ANGIOMAT ILLUMENA
    Manufacturer
    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
    Date Cleared
    1997-09-23

    (412 days)

    Product Code
    DXT
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.
    Device Description
    The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. The system is designed to be configured as cither an Angiographic injector or as a CT injector. The system includes a microprocessor controlled DC servo motor which drives a lead serve ram against the piston of a single use syringe. The operation of the servo is programmed by the operator using a touch screen on an electroluments on display. The system is powered by AC line voltage at 100 Volts, 130 Volts, or 240 Volts. System power is less than 1500 Walls. A typical Angiomat Illumena system includes a power pack, console, powerhead, syringe holder assembly, ac power cable assembly, start cable assembly, and console cable assembly. Other options include ECCG trigger systems, syringe heater, air detection and warning system, pedestal mounting system. wall/rack/ceiling mounting systems, interface cabling, powerhead and console extension cabling. Start switch variations, and printer system. The system is designed to deliver contrast from either a prefilled syringe or an unfilled wringe which is filled at the start of the procedure. A reusable, sterilizable syringe is also available. The system will interface with an X-ray system allowing either the start of injection initiated by the X-ray system or start of X-ray initiated by the injector.
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