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)

Sonix Health

K-Number: K230209 · 2023-10-20

ApplicantOntact Health Co., Ltd.
Decision Date2023-10-20
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sonix Health is a medical device manufactured by Ontact Health Co., Ltd.. It received FDA 510(k) clearance on 2023-10-20 under approval number K230209. 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 Sonix Health?

Sonix Health is a medical device that received FDA 510(k) clearance on 2023-10-20. It is manufactured by Ontact Health Co., Ltd.. The 510(k) number is K230209.

When was Sonix Health approved by the FDA?

Sonix Health received FDA 510(k) clearance on 2023-10-20, under approval number K230209.

What company makes Sonix Health?

Sonix Health is manufactured by Ontact Health Co., Ltd..

What is the FDA product code for Sonix Health?

The FDA product code for Sonix Health is QIH.

Other Devices by Ontact Health Co., Ltd.

K240645Sonix Health

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.

↑