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Imagine® Enterprise Suite — Softlink International Private Limited (510(k) K252634)

Imagine® Enterprise Suite — Softlink International Private Limited (510(k) K252634) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Imagine® Enterprise Suite; Applicant: Softlink International Private Limited; Clearance track: 510(k).

Device nameImagine® Enterprise Suite
ApplicantSoftlink International Private Limited
Clearance track510(k)
Submission numberK252634
DecisionSubstantially Equivalent
Decision date2026-01-16
Date received2025-08-20
Product codeQIH
Device class2
Medical specialtyRadiology
Applicant locationIN
SourceopenFDA device

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