FDA 510(k)

SmartCT (R3.0 (L10))

K号: K253670 · 2026-07-10

决定日期2026-07-10

产品代码OWB

咨询委员会RA

决定实质等同

器械摘要

SmartCT (R3.0 (L10)) is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems B.V.. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K253670. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SmartCT (R3.0 (L10))?

SmartCT (R3.0 (L10)) is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Philips Medical Systems B.V.. The 510(k) number is K253670.

When did SmartCT (R3.0 (L10)) receive FDA 510(k) clearance?

SmartCT (R3.0 (L10)) received FDA 510(k) clearance on 2026-07-10, under 510(k) number K253670.

Who is the listed applicant for SmartCT (R3.0 (L10))?

The FDA 510(k) record lists Philips Medical Systems B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartCT (R3.0 (L10))?

The FDA product code for SmartCT (R3.0 (L10)) is OWB.

列明Philips Medical Systems B.V.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。

K254186Azurion R3.1 K251827Azurion R3.1

官方来源

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