免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

内窥镜超声诊断设备/一次性无菌内窥镜超声探头（USW-S1，USW140-S20MS）

K号: K231889 · 2023-12-21

申请人Ultrasound Biotechnology (Shanghai) Co., Ltd.
决定日期2023-12-21
产品代码IYO
咨询委员会RA
决定实质等同

器械摘要

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasound Biotechnology (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2023-12-21 under 510(k) number K231889. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is a medical device that received FDA 510(k) clearance on 2023-12-21. The listed applicant is Ultrasound Biotechnology (Shanghai) Co., Ltd.. The 510(k) number is K231889.

When did Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) receive FDA 510(k) clearance?

Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) received FDA 510(k) clearance on 2023-12-21, under 510(k) number K231889.

Who is the listed applicant for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

The FDA 510(k) record lists Ultrasound Biotechnology (Shanghai) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS)?

The FDA product code for Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) is IYO.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：IYO）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260313MD-6000S 膀胱扫描仪MEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 型号 AQT Imaging Holdings, Inc.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

↑