Axial3D Cloud Segmentation Service
K-Number: K221511 · 2022-06-23
ApplicantAxial Medical Printing Limited
Decision Date2022-06-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Axial3D Cloud Segmentation Service is a medical device manufactured by Axial Medical Printing Limited. It received FDA 510(k) clearance on 2022-06-23 under approval number K221511. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Axial3D Cloud Segmentation Service?
Axial3D Cloud Segmentation Service is a medical device that received FDA 510(k) clearance on 2022-06-23. It is manufactured by Axial Medical Printing Limited. The 510(k) number is K221511.
When was Axial3D Cloud Segmentation Service approved by the FDA?
Axial3D Cloud Segmentation Service received FDA 510(k) clearance on 2022-06-23, under approval number K221511.
What company makes Axial3D Cloud Segmentation Service?
Axial3D Cloud Segmentation Service is manufactured by Axial Medical Printing Limited.
What is the FDA product code for Axial3D Cloud Segmentation Service?
The FDA product code for Axial3D Cloud Segmentation Service is LLZ.
Other Devices by Axial Medical Printing Limited
Related Devices (Code: LLZ)
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.