Imagine® Enterprise Suite— 510(k) K252634

Name: FDA 510(k) clearance K252634
Creator: U.S. Food and Drug Administration
Published: 2026-01-16

Substantially Equivalent

Softlink International Private Limited

FDA 510(k) clearance K252634 for Imagine® Enterprise Suite, Substantially Equivalent on 2026-01-16. Applicant: Softlink International Private Limited. Device class: 2.

Clearance details

Applicant: Softlink International Private Limited
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-08-20
Decision date: 2026-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aundh, IN

Download summary PDF View on FDA.gov ↗

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