FDA 510(k)

ChartCheck (RADCH V1.6)

K号: K252988 · 2026-01-05

决定日期2026-01-05

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

ChartCheck (RADCH V1.6) is the device name listed in this FDA 510(k) record. The listed applicant is Radformation, Inc.. It received FDA 510(k) clearance on 2026-01-05 under 510(k) number K252988. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ChartCheck (RADCH V1.6)?

ChartCheck (RADCH V1.6) is a medical device that received FDA 510(k) clearance on 2026-01-05. The listed applicant is Radformation, Inc.. The 510(k) number is K252988.

When did ChartCheck (RADCH V1.6) receive FDA 510(k) clearance?

ChartCheck (RADCH V1.6) received FDA 510(k) clearance on 2026-01-05, under 510(k) number K252988.

Who is the listed applicant for ChartCheck (RADCH V1.6)?

FDA 510(k)记录中列出Radformation, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for ChartCheck (RADCH V1.6)?

The FDA product code for ChartCheck (RADCH V1.6) is IYE.

列明Radformation, Inc.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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