FDA 510(k)

X-MIND prime（商標名為Acteon），I-MAX（商標名為Owandy Radiology）

K 號：K203374 · 2021-02-05

決定日期2021-02-05

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 De Götzen S.R.L. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MUH）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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