K Number
DEN230025Device Name
MIRA Surgical SystemManufacturer
Date Cleared
2024-02-23
(318 days)
Product Code
Regulation Number
878.4962Type
DirectReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
N/A