VistaSoft 4.0 and VisionX 4.0
K-Number: K250947 · 2025-08-27
ApplicantDurr Dental SE
Decision Date2025-08-27
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
VistaSoft 4.0 and VisionX 4.0 is a medical device manufactured by Durr Dental SE. It received FDA 510(k) clearance on 2025-08-27 under approval number K250947. 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 VistaSoft 4.0 and VisionX 4.0?
VistaSoft 4.0 and VisionX 4.0 is a medical device that received FDA 510(k) clearance on 2025-08-27. It is manufactured by Durr Dental SE. The 510(k) number is K250947.
When was VistaSoft 4.0 and VisionX 4.0 approved by the FDA?
VistaSoft 4.0 and VisionX 4.0 received FDA 510(k) clearance on 2025-08-27, under approval number K250947.
What company makes VistaSoft 4.0 and VisionX 4.0?
VistaSoft 4.0 and VisionX 4.0 is manufactured by Durr Dental SE.
What is the FDA product code for VistaSoft 4.0 and VisionX 4.0?
The FDA product code for VistaSoft 4.0 and VisionX 4.0 is QIH.
Other Devices by Durr Dental SE
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.