FDA 510(k)

SR-8100 便携式 X 射线单元

K号: K200637 · 2020-07-09

申请人Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)

决定日期2020-07-09

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

SR-8100 Portable X-ray Unit is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). It received FDA 510(k) clearance on 2020-07-09 under 510(k) number K200637. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SR-8100 Portable X-ray Unit?

SR-8100 Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2020-07-09. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). The 510(k) number is K200637.

When did SR-8100 Portable X-ray Unit receive FDA 510(k) clearance?

SR-8100 Portable X-ray Unit received FDA 510(k) clearance on 2020-07-09, under 510(k) number K200637.

Who is the listed applicant for SR-8100 Portable X-ray Unit?

The FDA 510(k) record lists Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SR-8100 Portable X-ray Unit?

The FDA product code for SR-8100 Portable X-ray Unit is IZL.

列明Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)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。

K210317Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G 数字彩色多普勒超声成像系统 K210318Apogee 6500,Apogee 6300,Apogee 6200 数字彩色多普勒超声成像系统 K202350SR-1000 便携式 DR 成像系统，SR-1000S 便携式 DR 成像系统 K202353SR-2300 便携式 DR 成像系统，SR-2300S 便携式 DR 成像系统 K200976SR-8230，SR-8230S 便携式 X 射线单元 K173000Apogee 2100 数字彩色多普勒超声成像系统 Apogee 2300 数字彩色多普勒超声成像系统

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