K252634

Substantially Equivalent

Imagine® Enterprise Suite

Applicant: Softlink International Private Limited
Product code: QIH
Advisory panel: Radiology
Date received: 2025-08-20
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aundh, IN

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Data sourced from openFDA. This site is unofficial and independent of the FDA.