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510(k) Data Aggregation
K Number
K250462Manufacturer
Date Cleared
2025-08-11
(174 days)
Product Code
Regulation Number
876.1500Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
UL UHD-Clear View 4K Camera System (UL-3Chip 4K)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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