免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

ATUSA® Automated 3D Breast Ultrasound System

K 號：K213620 · 2022-04-22

申請人Isono Health, Inc.
決定日期2022-04-22
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

ATUSA™ Automated 3D Breast Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Isono Health, Inc.. It received FDA 510(k) clearance on 2022-04-22 under 510(k) number K213620. 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 ATUSA™ Automated 3D Breast Ultrasound System?

ATUSA™ Automated 3D Breast Ultrasound System is a medical device that received FDA 510(k) clearance on 2022-04-22. The listed applicant is Isono Health, Inc.. The 510(k) number is K213620.

When did ATUSA™ Automated 3D Breast Ultrasound System receive FDA 510(k) clearance?

ATUSA™ Automated 3D Breast Ultrasound System received FDA 510(k) clearance on 2022-04-22, under 510(k) number K213620.

Who is the listed applicant for ATUSA™ Automated 3D Breast Ultrasound System?

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

What is the FDA product code for ATUSA™ Automated 3D Breast Ultrasound System?

The FDA product code for ATUSA™ Automated 3D Breast Ultrasound System 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

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 ApSK252237EdgeFlow 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。

↑