FDA 510(k)

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

K号: K252281 · 2025-11-18

决定日期2025-11-18

产品代码IZQ

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

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.

常见问题

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.

列明Ulrich GmbH & Co. KG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。

K251295ulrich注射CT运动（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）K210541ulrich注射CT运动 K202227Artus™颈椎板系统 K192872ulrich注射CT运动

查看所有 11 个设备 →

相关器械（代码：IZQ）

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。

K262115VueJect® 超声增强剂输送系统ACIST Medical Systems, Inc.K251295ulrich注射CT运动（XD 8000）Ulrich GmbH & Co. KG K252689MEDRAD Centargo CT 注射系统；MEDRAD Centargo 日用套件；MEDRAD Centargo 患者线；MEDRAD Centargo 替换针头；MEDRAD ISI2 模块（ISI2）Imaxeon Pty, Ltd.K241849MEDRAD Centargo CT 注射系统；MEDRAD Centargo 日用套件；MEDRAD Centargo 患者线；MEDRAD Centargo 替换针头；MEDRAD ISI2 模块（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

官方来源

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