FDA 510(k)

Delta4 Insight

K号: K223234 · 2024-01-16

决定日期2024-01-16

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Delta4 Insight is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K223234. 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 Delta4 Insight?

Delta4 Insight is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Scandidos AB. The 510(k) number is K223234.

When did Delta4 Insight receive FDA 510(k) clearance?

Delta4 Insight received FDA 510(k) clearance on 2024-01-16, under 510(k) number K223234.

Who is the listed applicant for Delta4 Insight?

The FDA 510(k) record lists Scandidos AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Delta4 Insight?

The FDA product code for Delta4 Insight is IYE.

列明Scandidos AB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。

K183606Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)K151426ScandiDos Delta4 Discover，备选商品名称：ScandiDos Delta4 Discover+

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。