(63 days)
Visage PACS/CS: is a system for distributing, viewing, and processing medical images and reports within and outside health care environments. It is to be used only by trained and instructed health care professionals. Visage PACS consists of the following components:
Visage PACS Storage: Visage PACS Storage offers an archiving option for long-term storage of image data
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within or outside a healthcare enterprise through web clients.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities
Integration with other hospital information systems (HIS, RIS, CIS) is provided via special interfaces.
Visage PACS is a system to distribute, view, and process medical images and reports within and outside of health care environments. It consists of the following components:
- Visage PACS Storage -
- Visage PACS Web -
- Visage CS -
Visage PACS Storage: A server receives image data in DICOM format via the hospital network. This provides universal connections to archives, modalities and workstations. Visage PACS Storage offers an archiving option for long-term storage of image data.
Visage PACS Web: Data that are stored on the Visage PACS Storage server can be accessed simultaneously by multiple web-based viewing stations within a healthcare enterprise or from elsewhere outside through web clients. The image data transfer is done in DICOM format via the Intranet or the Internet. Images can be viewed directly within a web browser (Internet Explorer). The system offers simple functions for image manipulation and measurements. Reports can be viewed together with the images on one page.
Visage CS: Visage CS is a client server system that uses thin client technology for distribution of 3D image data generated from image data of state-of-the-art scanning modalities. The thin client viewer allows to view and process 3D image data. No DICOM data is transferred to the client. Instead of image data, a stream of compressed screen content information is transmitted during interaction.
The provided document (K062496, VISAGE PACS/CS Premarket Submission Summary dated August 24, 2006) describes a Picture Archiving and Communications System (PACS) and does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
Instead, the submission focuses on:
- Substantial Equivalence: It asserts that the VISAGE PACS/CS is substantially equivalent to a predicate device (TeraRecon AquariusNet Server/Thin client, K012086). The "Substantial Equivalence Comparison Chart" (pages 5-6) details similarities in functionality, hardware/software requirements, and features between the Visage PACS/CS, the predicate device, and a previous version of the submitter's product (RADIN 3.0). This comparison serves as the primary and only "study" presented to demonstrate equivalency and fitness for purpose.
- Software Development Process and Risk Analysis: It states that the software was "designed, developed, tested and validated according to written procedures" and that a "risk analysis has been performed to identify all potential safety or health hazards."
Therefore, it is not possible to fill out the requested table and details because the submission does not include elements such as:
- Specific Acceptance Criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
- Device Performance Metrics against such criteria.
- Details of a test set (sample size, data provenance), ground truth establishment (number/qualifications of experts, adjudication methods, type of ground truth), or training set details.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.
The document aims to establish substantial equivalence primarily through a feature-by-feature comparison with a legally marketed predicate device, rather than through a direct clinical performance study with defined acceptance criteria and statistical analysis.
No study proving the device meets acceptance criteria regarding diagnostic performance or clinical effectiveness is described in this document. The safety and effectiveness claims are based on the device's substantial equivalence to a predicate device and adherence to quality system regulations and a risk management plan.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).