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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 the device name listed in this FDA 510(k) record. The listed applicant is Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-12-22 under 510(k) 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. The listed applicant is Qure.Ai Technologies. The 510(k) number is K231805.

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

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

Who is the listed applicant for qXR-LN?

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-LN?

The FDA product code for qXR-LN 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.

K251934qXR-DetectK251610qER-CTA (v1.0)K240740qCT LN QuantK231149qXR-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.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, 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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