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)

Segmentron Viewer

K-Number: K251072 · 2025-09-09

ApplicantDGNCT, LLC
Decision Date2025-09-09
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Segmentron Viewer is a medical device manufactured by DGNCT, LLC. It received FDA 510(k) clearance on 2025-09-09 under approval number K251072. 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 Segmentron Viewer?

Segmentron Viewer is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by DGNCT, LLC. The 510(k) number is K251072.

When was Segmentron Viewer approved by the FDA?

Segmentron Viewer received FDA 510(k) clearance on 2025-09-09, under approval number K251072.

What company makes Segmentron Viewer?

Segmentron Viewer is manufactured by DGNCT, LLC.

What is the FDA product code for Segmentron Viewer?

The FDA product code for Segmentron Viewer is QIH.

Other Devices by DGNCT, LLC

K252934Diagnocat

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.

↑