Delphi-MD System

• K Number: DEN250002
• Device Name: Delphi-MD System
• Manufacturer: QuantalX NeuroScience Ltd.
• Date Cleared: 2025-08-20 ( 229 days)
• Product Code: SFN
• Regulation Number: 882.1860
• Type: Direct
• Panel: Neurology
• Age Range: N/A
• 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

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