FDA 510(k)

InferOperate Suite

K号: K250237 · 2025-09-15

申请人Beijing Infervision Healthcare Medical Technology Co., Ltd.

决定日期2025-09-15

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

InferOperate Suite is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Infervision Healthcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-15 under 510(k) number K250237. 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 InferOperate Suite?

InferOperate Suite is a medical device that received FDA 510(k) clearance on 2025-09-15. The listed applicant is Beijing Infervision Healthcare Medical Technology Co., Ltd.. The 510(k) number is K250237.

When did InferOperate Suite receive FDA 510(k) clearance?

InferOperate Suite received FDA 510(k) clearance on 2025-09-15, under 510(k) number K250237.

Who is the listed applicant for InferOperate Suite?

The FDA 510(k) record lists Beijing Infervision Healthcare Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InferOperate Suite?

The FDA product code for InferOperate Suite is QIH.

列明Beijing Infervision Healthcare Medical Technology 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。

K260973InferOperate Suite K252261InferCare RECIST

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。