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)

PRAEVAorta®2

K-Number: K243859 · 2025-08-29

ApplicantNurea
Decision Date2025-08-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRAEVAorta®2 is a medical device manufactured by Nurea. It received FDA 510(k) clearance on 2025-08-29 under approval number K243859. 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 PRAEVAorta®2?

PRAEVAorta®2 is a medical device that received FDA 510(k) clearance on 2025-08-29. It is manufactured by Nurea. The 510(k) number is K243859.

When was PRAEVAorta®2 approved by the FDA?

PRAEVAorta®2 received FDA 510(k) clearance on 2025-08-29, under approval number K243859.

What company makes PRAEVAorta®2?

PRAEVAorta®2 is manufactured by Nurea.

What is the FDA product code for PRAEVAorta®2?

The FDA product code for PRAEVAorta®2 is QIH.

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.

↑