FDA 510(k)

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

K号: K203374 · 2021-02-05

决定日期2021-02-05

产品代码MUH

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决定实质等同

器械摘要

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is the device name listed in this FDA 510(k) record. The listed applicant is De Götzen S.R.L.. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203374. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is De Götzen S.R.L.. The 510(k) number is K203374.

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

X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203374.

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

The FDA 510(k) record lists De Götzen 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 (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology)?

The FDA product code for X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) is MUH.

列明De Götzen 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。

K231055x-mind dc（商标名下为Acteon），Owandy-RX DC（商标名下为OwandyRadiology）

官方来源

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