FDA 510(k)

攜帶式DR影像系統

K 號：K253058 · 2026-06-18

申請人Shantou Institute of Ultrasonic Instruments Co., Ltd.

決定日期2026-06-18

產品代碼IZL

諮詢委員會RA

決定相當於

器材摘要

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.

常見問題

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.

其他以 Shantou Institute of Ultrasonic Instruments Co., Ltd. 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。

相關器械（代碼：IZL）

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。

K260236XLITEGEMSS HEALTHCARE CO., LTD.K260085RAYMO移動X光系統（型號：RAYMO）DRGEM Corporation K253185Lux HD 檢測器，DRX-LC 檢測器，DRX-Revolution 移動 X 光系統Carestream Health K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.K251710移動X光單位 (!M1)Solutions For Tomorrow AB

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。