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imorgon Ultrasound PACS Solutions is a medical image and information management system that is intended to transmit, store, retrieve, print and process DICOM digital medical images and associated medical information from various ultrasound imaging systems. It may also be used for general radiogical viewing from other modalities such as MRI, CT or nuclear medicine.

imorqon Ultrasound PACS Solutions is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians and medical technologists. imorgon is also indicated for soft copy diagnostic interpretation of medical images and video by physicians trained in such practice.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

imorgon Ultrasound PACS Solutions is a PACS system, comprised of infor guisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central that pullent and prollowed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior syocedure data, a user can access the information by selecting the item from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components.

imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via internal formal, and customized is imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

This 510(k) submission for the imorgon Ultrasound PACS Solutions device does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (Siemens KinetDx PACS K023772) and details the general safety and effectiveness concerns related to the software development process. It confirms the device's intended use, its components, and that it has undergone "extensive testing" by various personnel.

However, the submission lacks specific details on:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• The number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Stand-alone (algorithm-only) performance studies.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

Without this specific information from the provided text, it's impossible to create the table and answer the questions as requested. The document confirms that testing and validation were performed, but it does not disclose the results or the methodology in a way that addresses your specific questions about acceptance criteria and performance study details.

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The intended use of the KinetDx system is for the acceptance, transfer, display, storage, and post-processing of digital medical images, including manipulation and quantification.

The KinetDx system is a digital image management system that includes a server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The system has workstations that can be used to review, edit, and manipulate image data; as well as review, generate quantitative data, qualitative data, and diagnostic reports.

The provided 510(k) summary for the KinetDx system (K041029) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on establishing substantial equivalence to previously cleared predicate devices (K023772 and K992259). It describes the device's intended use, general characteristics, and safety aspects, but it does not detail any performance claims or the results of a specific study to validate those claims against quantifiable acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions as the required information is not present in the provided text.

The document states:

• "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing."
• "In summary, Siemens is of the opinion that KinetDx does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."

These statements indicate that some form of verification and validation was performed to establish safety and substantial equivalence, but the details of these tests, including specific acceptance criteria and outcome measurements, are not included in this summary.

To provide the requested information, a different section of the 510(k) submission (e.g., performance testing reports) would be needed.

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