ARC-EX System

• K Number: K251821
• Device Name: ARC-EX System
• Manufacturer: Onward Medical Inc.
• Date Cleared: 2025-11-14 ( 154 days)
• Product Code: SDO
• Regulation Number: 890.5851
• Type: Traditional
• Panel: Neurology
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

N/A