qXR-BT
K-Number: K212690 · 2021-12-21
ApplicantQure.Ai Technologies
Decision Date2021-12-21
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
qXR-BT is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2021-12-21 under approval 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. It is manufactured by Qure.Ai Technologies. The 510(k) number is K212690.
When was qXR-BT approved by the FDA?
qXR-BT received FDA 510(k) clearance on 2021-12-21, under approval number K212690.
What company makes qXR-BT?
qXR-BT is manufactured by Qure.Ai Technologies.
What is the FDA product code for qXR-BT?
The FDA product code for qXR-BT is QIH.
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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.