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FDA 510(k)

膀胱掃描Prime PLUS系統

K 號：K172356 · 2017-09-15

申請人Verathon Incorporated
決定日期2017-09-15
產品代碼IYO
諮詢委員會RA
決定相當於

器材摘要

BladderScan Prime PLUS System is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Incorporated. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K172356. 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 BladderScan Prime PLUS System?

BladderScan Prime PLUS System is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Verathon Incorporated. The 510(k) number is K172356.

When did BladderScan Prime PLUS System receive FDA 510(k) clearance?

BladderScan Prime PLUS System received FDA 510(k) clearance on 2017-09-15, under 510(k) number K172356.

Who is the listed applicant for BladderScan Prime PLUS System?

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

What is the FDA product code for BladderScan Prime PLUS System?

The FDA product code for BladderScan Prime PLUS System 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

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。

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官方來源

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