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FDA 510(k)

qXR-BT

K-Number: K212690 · 2021-12-21

Decision Date2021-12-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

qXR-BT 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 2021-12-21 under 510(k) number K212690. 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-BT?

qXR-BT is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Qure.Ai Technologies. The 510(k) number is K212690.

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

qXR-BT received FDA 510(k) clearance on 2021-12-21, under 510(k) number K212690.

Who is the listed applicant for qXR-BT?

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-BT?

The FDA product code for qXR-BT 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.

View all 9 devices →

Related Devices (Code: QIH)

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.

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.