FDA 510(k)

ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)

K 號：K252281 · 2025-11-18

決定日期2025-11-18

產品代碼IZQ

諮詢委員會履歷

決定相當於

器材摘要

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is the device name listed in this FDA 510(k) record. The listed applicant is Ulrich GmbH & Co. KG. It received FDA 510(k) clearance on 2025-11-18 under 510(k) number K252281. The device is classified under product code IZQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is a medical device that received FDA 510(k) clearance on 2025-11-18. The listed applicant is Ulrich GmbH & Co. KG. The 510(k) number is K252281.

When did ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) receive FDA 510(k) clearance?

ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252281.

Who is the listed applicant for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

The FDA 510(k) record lists Ulrich GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)?

The FDA product code for ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) is IZQ.

其他以 Ulrich GmbH & Co. KG 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。

K251295烏爾里希注射CT動態 (XD 8000)K241850ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)K233737ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)K210541烏爾里希注射CT移動 K202227Artus™ cervical plate system K192872烏爾里希注射CT動態

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相關器械（代碼：IZQ）

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。

K262115VueJect® 超聲波增強劑輸送系統ACIST Medical Systems, Inc.K251295烏爾里希注射CT動態 (XD 8000)Ulrich GmbH & Co. KG K252689MEDRAD Centargo CT注射系統；MEDRAD Centargo日設；MEDRAD Centargo病人線；MEDRAD Centargo替換針頭；MEDRAD ISI2模組（ISI2）Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT注射系統；MEDRAD Centargo日設；MEDRAD Centargo病人線；MEDRAD Centargo替換針頭；MEDRAD ISI2模組（ISI2）Imaxeon Pty, Ltd.K241850ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG K233737ulricheasyINJECT Max 2M (XD 10140)；ulricheasyINJECT Max 3 (XD 10150)；ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG

官方來源

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