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510(k) Data Aggregation
K Number
K974863Device Name
IMIX DIGITAL THORAX SYSTEMManufacturer
Date Cleared
1998-03-17
(78 days)
Product Code
Regulation Number
892.1680Type
TraditionalPanel
RadiologyReference & Predicate Devices
N/A
Why did this record match?
Device Name :
IMIX DIGITAL THORAX SYSTEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
General Radiography as prescribed by competent authority.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving the device meets them. The text is a 510(k) clearance letter from the FDA for the IMIX Thorax, Vertical X-Ray Imaging System and pertains to the substantial equivalence determination for market authorization. It does not include performance metrics, study design details, or expert qualifications.
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