FDA 510(k)

uOmnispace.MR醫療設備規範文本翻譯： uOmnispace.MR醫療設備

K 號：K253077 · 2026-04-22

申請人Shanghai United Imaging Healthcare Co., Ltd.

決定日期2026-04-22

產品代碼QIH

諮詢委員會RA

決定相當於

器材摘要

uOmnispace.MR is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K253077. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the uOmnispace.MR?

uOmnispace.MR is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K253077.

When did uOmnispace.MR receive FDA 510(k) clearance?

uOmnispace.MR received FDA 510(k) clearance on 2026-04-22, under 510(k) number K253077.

Who is the listed applicant for uOmnispace.MR?

FDA 510(k) 記錄將上海聯合醫療儀器有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for uOmnispace.MR?

The FDA product code for uOmnispace.MR is QIH.

其他以 Shanghai United Imaging Healthcare Co., Ltd. 為申請人之記錄

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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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