Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Softlink International Private Limited. It received FDA 510(k) clearance on 2026-01-16 under approval 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. It is manufactured by Softlink International Private Limited. The 510(k) number is K252634.

When was Imagine® Enterprise Suite approved by the FDA?

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

What company makes Imagine® Enterprise Suite?

Imagine® Enterprise Suite is manufactured by Softlink International Private Limited.

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

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

Related Devices (Code: QIH)

K191647QLAB Advanced Quantification SoftwarePhilips Health Care K191171EchoGo CoreUltromics, Ltd. K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc. K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc. K202546LVivo SeamlessDia Imaging Analysis, Ltd. K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

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

↑