K Number
K253267

Validate with FDA (Live)

Device Name
CORIS System
Manufacturer
Date Cleared
2026-03-05

(157 days)

Product Code
Regulation Number
880.6994
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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N/A