(38 days)
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
The VIEW COM is a Software Device intended to digitized and to communicate Cardiac and Cardiovascular Images from the Procedure Room to Local Network in DICOM Format.
Such Digitized Images will be visualized and archivied by independent DICOM entities.
The provided document does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for the "VIEW COM" device, which is an Image Digitizer and Communication System. It focuses on demonstrating substantial equivalence to predicate devices. Key sections explicitly state:
- "CLINICAL PERFORMANCE DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)
- "CONCLUSION DRAWN FROM CLINICAL AND NONCLINICAL TEST DATA: Not required for determination of substantial equivalence for this class of device." (Page 3 of 5)
Therefore, none of the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details are available in this document. The manufacturer was not required by the FDA to perform such studies for the 510(k) clearance of this particular device.
§ 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).