FDA 510(k)

SubtleHD-CT (1.x)

K号: K254120 · 2026-05-15

决定日期2026-05-15

产品代码QIH

咨询委员会RA

决定实质等同

器械摘要

SubtleHD-CT (1.x) is the device name listed in this FDA 510(k) record. The listed applicant is Subtle Medical, Inc.. It received FDA 510(k) clearance on 2026-05-15 under 510(k) number K254120. 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 SubtleHD-CT (1.x)?

SubtleHD-CT (1.x) is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Subtle Medical, Inc.. The 510(k) number is K254120.

When did SubtleHD-CT (1.x) receive FDA 510(k) clearance?

SubtleHD-CT (1.x) received FDA 510(k) clearance on 2026-05-15, under 510(k) number K254120.

Who is the listed applicant for SubtleHD-CT (1.x)?

The FDA 510(k) record lists Subtle Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SubtleHD-CT (1.x)?

The FDA product code for SubtleHD-CT (1.x) is QIH.

列明Subtle Medical, 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。

K254013SubtleHD-PET (1.x)K243250SubtleHD (1.x)K240290AiMIFY (1.x)K241329SubtleSYNTH (1.x)K233699SubtleREFORMAT (1.x)K223623SubtleMR (2.3.x)

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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。