FDA 510(k)

SC1手持式超音波成像系統（型號：SC1）

K 號：K233579 · 2024-06-26

決定日期2024-06-26

產品代碼IYO

諮詢委員會RA

決定相當於

器材摘要

SC1 Handheld Ultrasound Imaging system (Model: SC1) is the device name listed in this FDA 510(k) record. The listed applicant is Fcu Co., Ltd.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K233579. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SC1 Handheld Ultrasound Imaging system (Model: SC1)?

SC1 Handheld Ultrasound Imaging system (Model: SC1) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is Fcu Co., Ltd.. The 510(k) number is K233579.

When did SC1 Handheld Ultrasound Imaging system (Model: SC1) receive FDA 510(k) clearance?

SC1 Handheld Ultrasound Imaging system (Model: SC1) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233579.

Who is the listed applicant for SC1 Handheld Ultrasound Imaging system (Model: SC1)?

The FDA 510(k) record lists Fcu Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SC1 Handheld Ultrasound Imaging system (Model: SC1)?

The FDA product code for SC1 Handheld Ultrasound Imaging system (Model: SC1) is IYO.

其他以 Fcu 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。

K210468SC1手持式超音波成像系統（型號：SC1）

相關器械（代碼：IYO）

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。

K260313MD-6000S 膀胱掃描儀MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApS K252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT 扫描儀 2000 型號 AQT Imaging Holdings, Inc.

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。