FDA 510(k)

ARTAssistant

K号: K250780 · 2025-12-05

决定日期2025-12-05

产品代码QKB

咨询委员会RA

决定实质等同

器械摘要

ARTAssistant is the device name listed in this FDA 510(k) record. The listed applicant is Manteia Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K250780. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARTAssistant?

ARTAssistant is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Manteia Technologies Co., Ltd.. The 510(k) number is K250780.

When did ARTAssistant receive FDA 510(k) clearance?

ARTAssistant received FDA 510(k) clearance on 2025-12-05, under 510(k) number K250780.

Who is the listed applicant for ARTAssistant?

FDA 510(k)记录将Manteia Technologies Co., Ltd.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for ARTAssistant?

The FDA product code for ARTAssistant is QKB.

列明Manteia Technologies Co., Ltd.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。

K260733MRIA 放射治疗信息系统（MRIA）K251351AccuContour 4.0 K250696AccuCheck K223834AccuCheck K223724MOZI TPS K221706AccuContour

查看所有 7 个设备 →

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。