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The GE Xtream Injector Option is designed to facilitate contrast-enhanced Computed Tomography (CT) by providing a method for connection and communication to the CT system with a compatible injector. When used, it allows the user to synchronize the start of the CT scan and the injector by pressing one single start button at the CT scanner. The GE Xtream Injector Option is based on the protocol contained in the CiA425 standard, and allows approved injectors to operate with certain GE Healthcare CT scanners that have the modified software and hardware interface required for the CiA425 communication protocol. This device is only the communication protocol and bus interface needed to communicate with a 510(k) cleared Injector that is compatible with the CiA425 standard.

The GE Xtream Injector Option is a software and hardware option that is based on the CANopen Injector Interface Standard (CiA 425). The CANopen communication protocol allows integration and synchronization of the CT system with the iniector. This option is an extension to the functionality of the existing GE CT systems and is designed to facilitate contrast-enhanced CT imaging by connecting the CT system and a 510(k) cleared compatible injector. The addition of this option to a GE CT Scanner simply implements an interface between the CT scanner and the injector following the defined communication standard. By utilizing this design standard, it will allow the Xtream Injector to operate any 510(k) cleared Injector that is compatible the CiA 425 standard. This option is being developed to be compatible with multiple GE CT scanners by adding the software and hardware components. As the software is integrated and verification is completed on the GE CT systems, a commercial introduction plan will be determined including appropriate Pre-Market Notifications for the CT systems.

The provided text is a 510(k) summary for the GE Xtream Injector Option. It describes a device that facilitates communication between a CT scanner and a compatible injector for contrast-enhanced CT imaging.

However, the document does not contain information about a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantitative measure of device performance as typically expected for diagnostic or analysis algorithms.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices (Toshiba Injector Synchronization Option and Siemens CARE CONTRAST CT) by emphasizing:

• Similar operating principle: Based on the CANopen Injector Interface Standard (CiA 425) for communication and synchronization.
• Similar indications for use: Facilitating contrast-enhanced CT by connecting and communicating with a compatible injector, allowing combined start of CT scan and injection with a single button.
• Adherence to standards and regulations: System verification and validation to specifications, federal regulations, user requirements, and adherence to industry/international standards (UL/CSA and IEC).
• Risk management: Identifying and controlling potential electrical, mechanical, and radiation hazards.

Therefore, I cannot fill out the requested table and answer the study-related questions as the information is not present in the provided text. The submission is for an "Accessory to Computed Tomography System" that implements a communication interface, and its compliance is largely based on adherence to communication standards and safety regulations, rather than clinical performance metrics in the way an AI diagnostic tool would be evaluated.

No study information regarding device performance metrics (e.g., accuracy, sensitivity, specificity) is provided in the document. The evaluation relies on demonstrating substantial equivalence in terms of design, principles of operation, and intended use, along with adherence to relevant safety and quality standards.

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