iotaSOFT® 執入系統
K 號：K252339 · 2026-01-09
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決定日期2026-01-09
產品代碼QQH
諮詢委員會中文(台灣):
此醫療設備之規範性文件遵循「醫療規範-v1」政策。以下為該文件之翻譯：
此醫療設備已通過美國食品藥品管理局（FDA）的510(k)認證，並獲得PMA許可。該設備的臨床試驗編號為NCTXXXXXXX，並在PubMed上以PMIDXXXXXXX登錄。該設備的識別碼為XXXXXXXX，相關資訊請參考以下網址：[URL]。
公司名稱：[公司名稱]
產品名稱：[產品名稱]
決定相當於
器材摘要
iotaSOFT® Insertion System is the device name listed in this FDA 510(k) record. The listed applicant is Iotamotion, Inc.. It received FDA 510(k) clearance on 2026-01-09 under 510(k) number K252339. The device is classified under product code QQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the iotaSOFT® Insertion System?
iotaSOFT® Insertion System is a medical device that received FDA 510(k) clearance on 2026-01-09. The listed applicant is Iotamotion, Inc.. The 510(k) number is K252339.
When did iotaSOFT® Insertion System receive FDA 510(k) clearance?
iotaSOFT® Insertion System received FDA 510(k) clearance on 2026-01-09, under 510(k) number K252339.
Who is the listed applicant for iotaSOFT® Insertion System?
The FDA 510(k) record lists Iotamotion, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for iotaSOFT® Insertion System?
The FDA product code for iotaSOFT® Insertion System is QQH.
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。
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。
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