FDA 510(k)

便携式DR成像系统

K号: K253058 · 2026-06-18

申请人Shantou Institute of Ultrasonic Instruments Co., Ltd.

决定日期2026-06-18

产品代码IZL

咨询委员会RA

决定实质等同

器械摘要

Portable DR Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K253058. 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 Portable DR Imaging System?

Portable DR Imaging System is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Shantou Institute of Ultrasonic Instruments Co., Ltd.. The 510(k) number is K253058.

When did Portable DR Imaging System receive FDA 510(k) clearance?

Portable DR Imaging System received FDA 510(k) clearance on 2026-06-18, under 510(k) number K253058.

Who is the listed applicant for Portable DR Imaging System?

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

What is the FDA product code for Portable DR Imaging System?

The FDA product code for Portable DR Imaging System is IZL.

列明Shantou Institute of Ultrasonic Instruments Co., Ltd.为申报人的其他记录

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