FDA 510(k)

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)

K号: K183606 · 2019-04-08

决定日期2019-04-08

产品代码IYE

咨询委员会RA

决定实质等同

器械摘要

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is the device name listed in this FDA 510(k) record. The listed applicant is Scandidos AB. It received FDA 510(k) clearance on 2019-04-08 under 510(k) number K183606. 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 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) is a medical device that received FDA 510(k) clearance on 2019-04-08. The listed applicant is Scandidos AB. The 510(k) number is K183606.

When did Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) receive FDA 510(k) clearance?

Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) received FDA 510(k) clearance on 2019-04-08, under 510(k) number K183606.

Who is the listed applicant for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

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 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW)?

The FDA product code for Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) 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。

K223234Delta4 Insight 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。