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FDA 510(k)

NemoScan

K-Number: K232698 · 2024-01-18

ApplicantSoftware Nemotec S.L.
Decision Date2024-01-18
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NemoScan is a medical device manufactured by Software Nemotec S.L.. It received FDA 510(k) clearance on 2024-01-18 under approval number K232698. 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 NemoScan?

NemoScan is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Software Nemotec S.L.. The 510(k) number is K232698.

When was NemoScan approved by the FDA?

NemoScan received FDA 510(k) clearance on 2024-01-18, under approval number K232698.

What company makes NemoScan?

NemoScan is manufactured by Software Nemotec S.L..

What is the FDA product code for NemoScan?

The FDA product code for NemoScan is QIH.

Other Devices by Software Nemotec S.L.

K192571NemoScan K193003NemoCast K192475NemoFAB K232549NemoCast

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.

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