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510(k) Data Aggregation
K Number
K023729Device Name
SIASCOPE IIManufacturer
Date Cleared
2003-02-03
(89 days)
Product Code
Regulation Number
878.4580Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SIASCOPE II
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
SIAscope is a non-invasive skin analysis system, which provides a synthesized 'image' showing the relative location of blood collagen and pigment.
Device Description
SIAscope is a non-invasive skin analysis system.
AI/ML Overview
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a device called SIAscope II. The letter primarily addresses the substantial equivalence determination and regulatory compliance. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.
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