(15 days)
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RiS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
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.
ImageGrid Web Viewer is a client/server software application and server that is designed to be used with the ImageGrid PACS device or as an independent service. The ImageGrid Web Viewer can query, retrieve, and display medical images that it retrieves from a DICOM SCP. The ImageGrid Web Viewer is a client/server software service that permits concurrent access to the ImageGrid PACS' medical images. ImageGrid™ can be integrated with an institutions HIS or RIS for an integrated electronic patient record.
ImageGrid™ is a software device and server that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources).
ImageGrid™ is a PACS solution, including: ImageGrid Web Viewer, ImageGrid OrderEntry, ImageGrid RIS, and ImageGrid Mammography Web Viewer.
Images (including mammography) and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.
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.
I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, a study conducted, sample sizes, ground truth establishment, or expert involvement. The document is a 510(k) summary for ImageGrid™ PACS, primarily focusing on its description, intended use, and substantial equivalence to predicate devices, but lacks the specific details requested regarding performance validation.
§ 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).