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FDA 510(k)

FibroScan® 產品系列（型號：502 Touch、530 Compact 及 430 Mini+）

K 號：K181547 · 2018-07-09

申請人Echosens
決定日期2018-07-09
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is the device name listed in this FDA 510(k) record. The listed applicant is Echosens. It received FDA 510(k) clearance on 2018-07-09 under 510(k) number K181547. 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 FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is a medical device that received FDA 510(k) clearance on 2018-07-09. The listed applicant is Echosens. The 510(k) number is K181547.

When did FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) receive FDA 510(k) clearance?

FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) received FDA 510(k) clearance on 2018-07-09, under 510(k) number K181547.

Who is the listed applicant for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)?

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

What is the FDA product code for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)?

The FDA product code for FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) is IYO.

相關臨床試驗

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。

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 Echosens 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。

K223902FibroScan®設備（型號：502 Touch、530 Compact、430 Mini+、230 和 630）K212035維博斯安230K203273FibroScan® 產品系列（型號：502 Touch、530 Compact、430 Mini+ 及 630）K200655FibroScan® 630K173034FibroScan® 產品系列（型號：502 Touch、530 Compact 及 430 Mini+）K172142FibroScan 430 Mini+

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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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官方來源

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