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510(k) Data Aggregation
(203 days)
MGD 2621P MEDICAL GREYSCALE DISPLAY
The MGD 2621P Medical Grayscale Display is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The MGD 2621P is a diagnostic display
The provided text is a 510(k) summary for the Barco MGD 2621P Medical Grayscale Display. This document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving the device meets these criteria.
The 510(k) summary focuses on general device information, intended use, and substantial equivalence to a predicate device (Barco MGD 221 2 Megapixel Diagnostic Display - K000293). It describes the device's technical characteristics as a high-resolution monitor with electronic capabilities for evaluating high-resolution medical images.
The letter from the FDA confirms market clearance based on substantial equivalence but does not delve into specific performance studies or acceptance criteria for the display itself. It mainly cites relevant regulations and guidelines for the manufacturer.
Therefore, I cannot provide the requested table or answer questions 1-9 based on the input text. The document is essentially a regulatory clearance notice, not a detailed performance study report.
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