FDA 510(k)

维斯塔软4.0和视界X 4.0

K号: K250947 · 2025-08-27

决定日期2025-08-27

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

VistaSoft 4.0 and VisionX 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental SE. It received FDA 510(k) clearance on 2025-08-27 under 510(k) number K250947. 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 VistaSoft 4.0 and VisionX 4.0?

VistaSoft 4.0 and VisionX 4.0 is a medical device that received FDA 510(k) clearance on 2025-08-27. The listed applicant is Durr Dental SE. The 510(k) number is K250947.

When did VistaSoft 4.0 and VisionX 4.0 receive FDA 510(k) clearance?

VistaSoft 4.0 and VisionX 4.0 received FDA 510(k) clearance on 2025-08-27, under 510(k) number K250947.

Who is the listed applicant for VistaSoft 4.0 and VisionX 4.0?

The FDA 510(k) record lists Durr Dental SE as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VistaSoft 4.0 and VisionX 4.0?

The FDA product code for VistaSoft 4.0 and VisionX 4.0 is QIH.

列明Durr Dental SE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。

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官方来源

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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。