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FDA 510(k)

剪力波定量超聲診斷系統（Mini900、Mini990、Mini800、Mini790、Mini780、Mini560、Mini300、Mini100、FT100）

K 號：K243880 · 2025-06-17

申請人Wuxi Hisky Medical Technologies Co., Ltd.
決定日期2025-06-17
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is the device name listed in this FDA 510(k) record. The listed applicant is Wuxi Hisky Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-06-17 under 510(k) number K243880. 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 Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is a medical device that received FDA 510(k) clearance on 2025-06-17. The listed applicant is Wuxi Hisky Medical Technologies Co., Ltd.. The 510(k) number is K243880.

When did Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) receive FDA 510(k) clearance?

Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) received FDA 510(k) clearance on 2025-06-17, under 510(k) number K243880.

Who is the listed applicant for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

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

What is the FDA product code for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100)?

The FDA product code for Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) is IYO.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Wuxi Hisky Medical Technologies 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。

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