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)

qCT LN Quant

K-Number: K240740 · 2024-08-16

ApplicantQure.Ai Technologies
Decision Date2024-08-16
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qCT LN Quant is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2024-08-16 under approval number K240740. 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 qCT LN Quant?

qCT LN Quant is a medical device that received FDA 510(k) clearance on 2024-08-16. It is manufactured by Qure.Ai Technologies. The 510(k) number is K240740.

When was qCT LN Quant approved by the FDA?

qCT LN Quant received FDA 510(k) clearance on 2024-08-16, under approval number K240740.

What company makes qCT LN Quant?

qCT LN Quant is manufactured by Qure.Ai Technologies.

What is the FDA product code for qCT LN Quant?

The FDA product code for qCT LN Quant is QIH.

Other Devices by Qure.Ai Technologies

K200921qER K212690qXR-BT K211222qER-Quant K231805qXR-LN K231149qXR-CTR K230899qXR-PTX-PE

View all 9 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.

↑