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510(k) Data Aggregation
K Number
K993958Device Name
IDX-60 INTRAORAL X-RAYManufacturer
Date Cleared
2000-02-14
(84 days)
Product Code
Regulation Number
872.1800Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Not Found
Device Description
IDX-160 Extraoral Source Dental X-Ray
AI/ML Overview
The provided documents are FDA 510(k) clearance letters for the "IDX-160 Extraoral Source Dental X-Ray" and "In X-60 Extraoral Source Dental X-Ray". These documents primarily focus on the regulatory classification and substantial equivalence determination for the devices. They do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information based on the given text. The documents do not describe a study that proves the device meets acceptance criteria.
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