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510(k) Data Aggregation
K Number
K062265Device Name
CT EXPRES III CONTRAST MEDIA DELIVERY SYSTEM
Manufacturer
SWISS MEDICAL CARE S.A.
Date Cleared
2006-12-26
(144 days)
Product Code
IZQ
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
SWISS MEDICAL CARE S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CT Exprés III™ Contrast Media Delivery System (CMDS) is indicated for controlled automatic administration, on the venous side, of contrast media (CM) to human subjects while undergoing examination by means of a computed tomography (CT) scanner.
The system consists of the CT Exprés III™ Instrument, the Bottle Spike, the Day Set III, the Patient Set, accessories and detachable parts.
This device is not intended for injection of CM for coronary arteriography, or for any other use for which the device is not indicated.
This device is only to be operated by and under quasi-continuous supervision of qualified medical staff in an appropriate licensed health care facility.
Device Description
The CT Exprés III™ Contrast Media Delivery System (CMDS) is a programmable, software driven, electromechanical, high-pressure contrast media injection system.
The positive pressure necessary for the injection is generated by a disposable rotary peristaltic cassette, located inside one of the disposable (Patient Set).
The CT Exprés III™ Contrast Media Delivery System consists of the main following elements:
- . The instrument, i.e. the main unit (injector unit and power supply), the main control panel, and associated cables.
- . Accessories, i.e. the handswitch.
- Detachable parts, i.e. the remote control panel, the bottle insulators, and the pedestal pole. .
- Three associated proprietary disposables creating a complete fluidic pathway from the . bottle of CM to the patient, i.e. the "Bottle Spike", the "Day Set III" and the "Patient Set".
The printer and ceiling mount are provided as optional devices for use in combination with the CT Exprés III™.
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