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510(k) Data Aggregation

K Number

Device Name

OmniTom Elite with PCD

Manufacturer

NeuroLogica Corporation

Date Cleared

2025-09-08

(164 days)

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Regulation Number

Type

Panel

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Device Name :

OmniTom Elite with PCD

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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