FDA 510(k)

i_Space 1.5T 超导磁共振成像系统

K号: K192650 · 2021-01-29

申请人Mri Division,Beijing Wandong Medical Technology Co., Ltd.

决定日期2021-01-29

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

i_Space 1.5T Superconducting Magnetic Resonance Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Mri Division,Beijing Wandong Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) number K192650. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

i_Space 1.5T Superconducting Magnetic Resonance Imaging System is a medical device that received FDA 510(k) clearance on 2021-01-29. The listed applicant is Mri Division,Beijing Wandong Medical Technology Co., Ltd.. The 510(k) number is K192650.

When did i_Space 1.5T Superconducting Magnetic Resonance Imaging System receive FDA 510(k) clearance?

i_Space 1.5T Superconducting Magnetic Resonance Imaging System received FDA 510(k) clearance on 2021-01-29, under 510(k) number K192650.

Who is the listed applicant for i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

The FDA 510(k) record lists Mri Division,Beijing Wandong Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i_Space 1.5T Superconducting Magnetic Resonance Imaging System?

The FDA product code for i_Space 1.5T Superconducting Magnetic Resonance Imaging System is LNH.

列明Mri Division,Beijing Wandong Medical Technology Co., Ltd.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。

K221025i_ 字段 1.5T 超导磁共振成像系统

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