qXR-PTX-PE
K-Number: K230899 · 2023-08-22
ApplicantQure.Ai Technologies
Decision Date2023-08-22
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
qXR-PTX-PE is a medical device manufactured by Qure.Ai Technologies. It received FDA 510(k) clearance on 2023-08-22 under approval number K230899. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the qXR-PTX-PE?
qXR-PTX-PE is a medical device that received FDA 510(k) clearance on 2023-08-22. It is manufactured by Qure.Ai Technologies. The 510(k) number is K230899.
When was qXR-PTX-PE approved by the FDA?
qXR-PTX-PE received FDA 510(k) clearance on 2023-08-22, under approval number K230899.
What company makes qXR-PTX-PE?
qXR-PTX-PE is manufactured by Qure.Ai Technologies.
What is the FDA product code for qXR-PTX-PE?
The FDA product code for qXR-PTX-PE is QFM.
Other Devices by Qure.Ai Technologies
Related Devices (Code: QFM)
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.