FDA 510(k)

Imagine® Enterprise Suite

Número K: K252634 · 2026-01-16

RequerenteSoftlink International Private Limited

Data da decisão2026-01-16

Código do produtoQIH

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

Imagine® Enterprise Suite is the device name listed in this FDA 510(k) record. The listed applicant is Softlink International Private Limited. It received FDA 510(k) clearance on 2026-01-16 under 510(k) number K252634. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Imagine® Enterprise Suite?

Imagine® Enterprise Suite is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Softlink International Private Limited. The 510(k) number is K252634.

When did Imagine® Enterprise Suite receive FDA 510(k) clearance?

Imagine® Enterprise Suite received FDA 510(k) clearance on 2026-01-16, under 510(k) number K252634.

Who is the listed applicant for Imagine® Enterprise Suite?

The FDA 510(k) record lists Softlink International Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Imagine® Enterprise Suite?

The FDA product code for Imagine® Enterprise Suite is QIH.

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