Axial3D Insight
K-Number: K232841 · 2023-11-15
ApplicantAxial Medical Printing Limited
Decision Date2023-11-15
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Axial3D Insight is a medical device manufactured by Axial Medical Printing Limited. It received FDA 510(k) clearance on 2023-11-15 under approval number K232841. 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 Axial3D Insight?
Axial3D Insight is a medical device that received FDA 510(k) clearance on 2023-11-15. It is manufactured by Axial Medical Printing Limited. The 510(k) number is K232841.
When was Axial3D Insight approved by the FDA?
Axial3D Insight received FDA 510(k) clearance on 2023-11-15, under approval number K232841.
What company makes Axial3D Insight?
Axial3D Insight is manufactured by Axial Medical Printing Limited.
What is the FDA product code for Axial3D Insight?
The FDA product code for Axial3D Insight 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.