FDA 510(k)

qXR-CTR

K-Number: K231149 · 2023-09-22

Decision Date2023-09-22

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

qXR-CTR 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 2023-09-22 under 510(k) number K231149. 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 qXR-CTR?

qXR-CTR is a medical device that received FDA 510(k) clearance on 2023-09-22. The listed applicant is Qure.Ai Technologies. The 510(k) number is K231149.

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

qXR-CTR received FDA 510(k) clearance on 2023-09-22, under 510(k) number K231149.

Who is the listed applicant for qXR-CTR?

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-CTR?

The FDA product code for qXR-CTR is QIH.

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.

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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.