FDA 510(k)

Axial3D Insight

K-Number: K222745 · 2023-07-03

Decision Date2023-07-03

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Axial3D Insight 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 2023-07-03 under 510(k) number K222745. 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 2023-07-03. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K222745.

When did Axial3D Insight receive FDA 510(k) clearance?

Axial3D Insight received FDA 510(k) clearance on 2023-07-03, under 510(k) number K222745.

Who is the listed applicant for Axial3D Insight?

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 Insight?

The FDA product code for Axial3D Insight is QIH.

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 Insight K231607Axial3D Cloud Segmentation Service K232841Axial3D Insight K221511Axial3D Cloud Segmentation Service

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.