FDA 510(k)

X-MIND prime 3D（商标名下为Acteon），I-MAX 3D（商标名下为Owandy Radiology）

K号: K201382 · 2020-11-18

决定日期2020-11-18

产品代码OAS

咨询委员会RA

决定实质等同

器械摘要

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Gotzen S.R.L.. It received FDA 510(k) clearance on 2020-11-18 under 510(k) number K201382. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2020-11-18. The listed applicant is De Gotzen S.R.L.. The 510(k) number is K201382.

When did X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) receive FDA 510(k) clearance?

X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) received FDA 510(k) clearance on 2020-11-18, under 510(k) number K201382.

Who is the listed applicant for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

The FDA 510(k) record lists De Gotzen S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology)?

The FDA product code for X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) is OAS.

列明De Gotzen S.R.L.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。

K191719X-MIND 三冠 K192165Acteon 成像套件 K160166X-MIND 三维

官方来源

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