(15 days)
iSite PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians. The system is used with general purpose computing hardware to acquire, transmit, process and store images and data throughout a clinical environment. Data and images are acquired through DICOM compliant imaging device or modalities.
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.
iSite is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
The system is a software package that is used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage.
iSite supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CT, MR, NM, US, XA, PET, DX, DR, RF, RT, MG, SC, VL, as well as hospital/radiology information systems.
The provided text (K042292) is a 510(k) summary for the iSite PACS v3.3 software. It describes the device, its intended use, and states that it is substantially equivalent to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states:
- "Stentor certifies that the iSite software is designed, developed, tested and validated according to written procedures."
- "iSite is substantially equivalent in design and intended use to diagnostic radiological workstations. PACS and image management systems as substantiated in the feature comparison. Any differences between the iSite PACS software and the equivalent devices have no significant influence on safety or effectiveness. Therefore, iSite PACS raises no new issues of safety or effectiveness from its predicate devices."
This indicates that the device's approval was based on demonstrating substantial equivalence to existing predicate devices, rather than a specific performance study against predefined acceptance criteria for a new clinical claim. The 510(k) process often relies on this substantial equivalence demonstration for devices that are not making novel claims requiring new clinical evidence.
Therefore, the requested information elements cannot be extracted from the provided text as the document does not include data from a performance study comparing the device against specific acceptance criteria.
§ 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).