FDA 510(k)

Axial3D Insight

K号: K250369 · 2025-09-18

决定日期2025-09-18

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

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 2025-09-18 under 510(k) number K250369. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Axial3D Insight?

Axial3D Insight is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is Axial Medical Printing Limited. The 510(k) number is K250369.

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

Axial3D Insight received FDA 510(k) clearance on 2025-09-18, under 510(k) number K250369.

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.

列明Axial Medical Printing Limited为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K231607Axial3D Cloud Segmentation Service K232841Axial3D Insight K222745Axial3D Insight K221511Axial3D Cloud Segmentation Service

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。