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Dynamic Healthcare Technologies' PACSPlus, version 2.0, is indicated for use by radiology professionals to capture, store, distribute and display radiological images and information over local and Wide Area Networks. The only editing of the images is via the wavelet lossy compression feature, using the Pegasus PICtools ™ Medical Compression toolkit, a 510(k)-cleared medical device product (K#982146).

"Dynamic PACSPlus Version 2.0 is an information-enabled PACS (Picture Archiving and Communication System) that integrates all information from the RIS with images from PACS. Image capture is available from most imaging modalities using DICOM interfaces and selected non-DICOM interfaces. PACSPlus InfoBroker Servers are used as gateways that capture the DICOM images, reconcile the DICOM information with order information from the RIS, and provide access to additional exam and patient information including results. The PACSPlus Image and Information Server stores, indexes, and distributes images and information. Images can be viewed through the web-based Dynamic WebSight viewer. Exams can be accessed by patient identifiers, location, or by physician. The entire imaging exam history is shown (film and digital) to allow the viewer to select any results or available digital images. " (source: Product Fact Sheet, Dynamic Healthcare Technologies, Inc.)

This document does not contain an acceptance criteria table, device performance data, details on a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts, adjudication methods, details of a multi-reader multi-case study, or standalone algorithm performance.

The provided text is a summary of a Special 510(k) Modification Submission for Dynamic PACSPlus, version 2.0. It describes the device, its intended use, and a safety statement. It also includes the FDA's letter granting substantial equivalence.

The FDA's decision is based on a comparison to a predicate device (MaxiView Radiology Workstation, K930500) and compliance with general controls, including good manufacturing practices. There is no mention of a specific clinical study with acceptance criteria to demonstrate performance beyond a comparison to the predicate device.

The "Indications for Use Statement" mentions that the only editing of images is via the wavelet lossy compression feature, using the Pegasus PICtools™ Medical Compression toolkit, which is a 510(k)-cleared medical device product (K#982146). This indicates that the image compression component itself has been evaluated, but the overall PACSPlus system's performance metrics are not described here.

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