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FDA 510(k)

qXR-Detect

K-Number: K251934 · 2026-01-16

ApplicantQure.Ai Technologies
Decision Date2026-01-16
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qXR-Detect is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2026-01-16 under approval number K251934. 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-Detect?

qXR-Detect is a medical device that received FDA 510(k) clearance on 2026-01-16. It is manufactured by Qure.Ai Technologies. The 510(k) number is K251934.

When was qXR-Detect approved by the FDA?

qXR-Detect received FDA 510(k) clearance on 2026-01-16, under approval number K251934.

What company makes qXR-Detect?

qXR-Detect is manufactured by Qure.Ai Technologies.

What is the FDA product code for qXR-Detect?

The FDA product code for qXR-Detect is MYN.

Other Devices by Qure.Ai Technologies

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

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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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