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FDA 510(k)

Axial3D Cloud Segmentation Service

K-Number: K231607 · 2024-01-24

ApplicantAxial Medical Printing Limited
Decision Date2024-01-24
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Axial3D Cloud Segmentation Service is the device name listed in this FDA 510(k) record. The listed applicant is Axial Medical Printing Limited. It received FDA 510(k) clearance on 2024-01-24 under 510(k) number K231607. 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 2024-01-24. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K231607.

When did Axial3D Cloud Segmentation Service receive FDA 510(k) clearance?

Axial3D Cloud Segmentation Service received FDA 510(k) clearance on 2024-01-24, under 510(k) number K231607.

Who is the listed applicant for Axial3D Cloud Segmentation Service?

The FDA 510(k) record lists Axial Medical Printing Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Axial3D Cloud Segmentation Service?

The FDA product code for Axial3D Cloud Segmentation Service is LLZ.

Other records listing Axial Medical Printing Limited 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.

K250369Axial3D InsightK232841Axial3D InsightK222745Axial3D InsightK221511Axial3D Cloud Segmentation Service

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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.

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