Overjet CBCT Assist
K-Number: K251514 · 2025-12-05
ApplicantOverjet, Inc.
Decision Date2025-12-05
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Overjet CBCT Assist is a medical device manufactured by Overjet, Inc.. It received FDA 510(k) clearance on 2025-12-05 under approval number K251514. 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 Overjet CBCT Assist?
Overjet CBCT Assist is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Overjet, Inc.. The 510(k) number is K251514.
When was Overjet CBCT Assist approved by the FDA?
Overjet CBCT Assist received FDA 510(k) clearance on 2025-12-05, under approval number K251514.
What company makes Overjet CBCT Assist?
Overjet CBCT Assist is manufactured by Overjet, Inc..
What is the FDA product code for Overjet CBCT Assist?
The FDA product code for Overjet CBCT Assist is QIH.
Other Devices by Overjet, Inc.
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.