Imagine® Enterprise Suite

• K Number: K252634
• Device Name: Imagine® Enterprise Suite
• Manufacturer: Softlink International Private Limited
• Date Cleared: 2026-01-16 ( 149 days)
• Product Code: QIH
• Regulation Number: 892.2050
• Type: Traditional
• Panel: Radiology
• 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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