FDA 510(k)

Viz Subdural+, Viz SUBDURAL PLUS

K-Number: K250354 · 2025-06-10

Decision Date2025-06-10

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Viz Subdural+, Viz SUBDURAL PLUS is a medical device manufactured by Viz. Ai, Inc.. It received FDA 510(k) clearance on 2025-06-10 under approval number K250354. 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 Viz Subdural+, Viz SUBDURAL PLUS?

Viz Subdural+, Viz SUBDURAL PLUS is a medical device that received FDA 510(k) clearance on 2025-06-10. It is manufactured by Viz. Ai, Inc.. The 510(k) number is K250354.

When was Viz Subdural+, Viz SUBDURAL PLUS approved by the FDA?

Viz Subdural+, Viz SUBDURAL PLUS received FDA 510(k) clearance on 2025-06-10, under approval number K250354.

What company makes Viz Subdural+, Viz SUBDURAL PLUS?

Viz Subdural+, Viz SUBDURAL PLUS is manufactured by Viz. Ai, Inc..

What is the FDA product code for Viz Subdural+, Viz SUBDURAL PLUS?

The FDA product code for Viz Subdural+, Viz SUBDURAL PLUS is QIH.

Other Devices by Viz. Ai, Inc.

K180161Viz CTP K193658Viz ICH K210209Viz ICH K223042Viz LVO ContaCT K221100Viz RV/LV K220439Viz SDH

View all 11 devices →

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.