Search Results

Edge PACS™ is a software device (server, web viewer, & workstation) used for diagnostic viewing and manipulating medical images. Digital images and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software.

Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.

Edge PACS, is a software device that consists of the Radion Workstation, Edge PACS Web Viewer, and Edge PACS Server and can be used for diagnostic viewing and manipulating of medical images. Digital images (including mammography and data from various sources (including CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or imaging sources) can be displayed, processed, stored and communicated across computer networks using this software. Edge PACS™ can be integrated with an institution's existing Hospital Information System (HIS) or Radiology Information System (RIS) providing access to reports for fully-integrated electronic patient records.

Edge PACS allows medical imaging centers to easily record patient details with study information along with their images and to prepare reports that can be distributed to the patient either in paper printout or through the Internet (email).

Moreover, it allows the user to retrieve images easily and to compare the images of the patient between different visits or to distribute the patient records in CD's. It also allows generating statistical data from the available details. Overall features include:

• . Prevent unauthorized access of Patient Records
• . Easy search of Patient details
• Flexibility to design auto patient ID .
• Report transmission by mail .
• . Cropping of live images
• Editing of AVI/cine loops .
• . Distribution of Reports and Images in CD
• . Comparison of images between different visits of patient
• Tagging of significant images/cineloop for future references .
• Generation of statistical data from available details .

The provided 510(k) summary for the Edge PACS™ primarily focuses on establishing substantial equivalence to a predicate device, as required for regulatory clearance. It does not include information about acceptance criteria for device performance, nor does it detail a study that proves the device meets such criteria.

The document describes the device's function as a Picture Archiving Communications System (PACS) for viewing, manipulating, and storing medical images. It highlights features like patient record management, image comparison, and integration with HIS/RIS. However, it does not provide any performance metrics, clinical study results, or validation against specific technical or clinical acceptance criteria.

The 510(k) process for this type of device (a PACS system) often relies on demonstrating that the new device has the same technological characteristics and indications for use as a legally marketed predicate device, rather than requiring extensive clinical efficacy studies with predefined acceptance criteria for diagnostic performance.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

The document confirms that this is a 510(k) submission, and the FDA's letter acknowledges that the device is substantially equivalent to the predicate. This means the device met the regulatory requirements for clearance based on its similarity to an already approved device, rather than a separate performance study against specific acceptance criteria.

Ask a specific question about this device