(106 days)
VIEW1 Imaging is a software that receives digital images and data from existing imaging equipment using DICOM 3.0 communication protocols and is not recommended for primary diagnosis. Images and data are stored on the server in deflate image and JPEG.
VIEW1 Imaging is designed to serve as an accessory to a Picture Archiving and Communication System (PACS). It is used with general purpose computing hardware for the display of medical image data as well as patient information. It is designed to provide storage, routing and display of DICOM image data through an executable program as well as in a web based format.
VIEW1 Imaging is intended for use as a tool by trained professionals such as physicians and must not be reviewed for primary image interpretations of Mammography images.
VIEW1 Imaging uses three different interfaces: HL7, DICOM and Image Generator to present, transmit and stored clinical data and digital images to physicians to be used as a review tool. It also allow physicians to access these data and images via any standard web browser-based devices.
It appears there is some confusion in the provided text. The document is a 510(k) summary for a medical device called "VIEW1 Imaging," which is a software for displaying medical images. However, the document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence to a predicate device (IMCO-STAT, K063392) rather than presenting performance data from a specific study against predefined acceptance criteria. This type of submission (510(k)) primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device, often by showing similar technological characteristics and indications for use.
Therefore, I cannot provide the requested information because it is not present in the given text. The text explicitly states:
- "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements... All data included in this document is accurate and complete..."
- "Substantial Equivalence: VIEW1 Imaging is substantially equivalent to IMCO-STAT (K063392)."
- "The minor differences between the subject and the predicate device do not raise any new issues of safety and efficacy."
These statements indicate the primary goal of the submission is to demonstrate equivalence, not to detail performance against specific acceptance criteria through a clinical or technical study.
§ 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).