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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 the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2026-01-16 under 510(k) 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. The listed applicant is Qure.Ai Technologies. The 510(k) number is K251934.

When did qXR-Detect receive FDA 510(k) clearance?

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

Who is the listed applicant for qXR-Detect?

The FDA 510(k) record lists Qure.Ai Technologies as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for qXR-Detect?

The FDA product code for qXR-Detect is MYN.

Other records listing Qure.Ai Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251610qER-CTA (v1.0)K240740qCT LN QuantK231805qXR-LNK231149qXR-CTRK230899qXR-PTX-PEK212690qXR-BT

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Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, Inc.K252086DTX Studio AssistNobel Biocare C/O Medicim NV

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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