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510(k) Data Aggregation
K Number
K993780Device Name
QSC-300 SHOULDER ARRAY COILSManufacturer
Date Cleared
1999-11-26
(18 days)
Product Code
Regulation Number
892.1000Type
SpecialPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the shoulder that can be interpreted by a trained physician.
Device Description
Model QSC-300 Shoulder Array Coils
AI/ML Overview
This is a 510(k) premarket notification letter for the Model QSC-300 Shoulder Array Coil, dated November 26, 1999. It determines that the device is substantially equivalent to legally marketed predicate devices. This document does not contain details about acceptance criteria or a study proving device performance as it predates the current standards for AI/ML device submissions by several decades.
Therefore, I cannot provide the requested information from the given text.
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