(15 days)
The PrimeVue 21 inch 3MP Radiological Medical Display is intended to be used to display and view digital images for review and analysis by trained medical practitioners. However, This device must not be used in primary image diagnosis in mammography.
The PrimeVue 21 inch 3MP Color Display is a diagnostic display. The PrimeVue 21 inch 3MP Display is a high-resolution Liquid Crystal Display (LCD) with electronic capabilities used for the review and analysis of high-resolution medical images by trained medical practitioners.
This document indicates that the PrimeVue 21" 3MP Color Display is a diagnostic display intended for review and analysis of digital images by trained medical practitioners. It explicitly states that it must not be used in primary image diagnosis in mammography. The document is a 510(k) summary for the device.
However, the provided text does not contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria. It is a regulatory submission for premarket notification, establishing substantial equivalence to predicate devices. It discusses:
- Manufacturer and device details: NDS Surgical Imaging, LLC, PrimeVue 21" 3MP Color Display.
- Intended Use: Display and view digital images for review and analysis by trained medical practitioners (excluding primary image diagnosis in mammography).
- Technological Characteristics: High-resolution Liquid Crystal Display (LCD) with electronic capabilities for review and analysis of high-resolution medical images.
- Substantial Equivalence: Listing predicate devices (Coronis, Mdnc 3120 (Barco) K061927; RadiForce R31-C (Eizo Nanao) K052344).
- Regulatory Classification: 21 CFR 892.2050/Procode 90LLZ (System, image processing, radiological).
Therefore, I cannot provide the requested information about acceptance criteria, device performance, or studies from the provided text. The document focuses on regulatory approval based on substantial equivalence, not on performance studies 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).