FDA 510(k)

Imagine® Enterprise Suite

K-Number: K252634 · 2026-01-16

ApplicantSoftlink International Private Limited

Decision Date2026-01-16

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbH K253902RealGUIDE3DIEMME SRL K253835AffinityHermes Medical Solutions AB K260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.