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FDA 510(k)

qXR-LN

K-Number: K231805 · 2023-12-22

ApplicantQure.Ai Technologies
Decision Date2023-12-22
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qXR-LN is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-12-22 under approval number K231805. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the qXR-LN?

qXR-LN is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Qure.Ai Technologies. The 510(k) number is K231805.

When was qXR-LN approved by the FDA?

qXR-LN received FDA 510(k) clearance on 2023-12-22, under approval number K231805.

What company makes qXR-LN?

qXR-LN is manufactured by Qure.Ai Technologies.

What is the FDA product code for qXR-LN?

The FDA product code for qXR-LN is MYN.

Other Devices by Qure.Ai Technologies

K200921qER K212690qXR-BT K211222qER-Quant K231149qXR-CTR K230899qXR-PTX-PE K240740qCT LN Quant

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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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