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FDA 510(k)

PillCam™ Genius SB 系统，配备 PillCam 软件 v9.7 和 PillCam Cloud Reader 软件

K号: K240276 · 2024-05-10

申请人Given Imaging Ltd. (D.B.A. Medtronic)
决定日期2024-05-10
产品代码NEZ
咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
决定实质等同

器械摘要

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is the device name listed in this FDA 510(k) record. The listed applicant is Given Imaging Ltd. (D.B.A. Medtronic). It received FDA 510(k) clearance on 2024-05-10 under 510(k) number K240276. The device is classified under product code NEZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is a medical device that received FDA 510(k) clearance on 2024-05-10. The listed applicant is Given Imaging Ltd. (D.B.A. Medtronic). The 510(k) number is K240276.

When did PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software receive FDA 510(k) clearance?

PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software received FDA 510(k) clearance on 2024-05-10, under 510(k) number K240276.

Who is the listed applicant for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

The FDA 510(k) record lists Given Imaging Ltd. (D.B.A. Medtronic) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software?

The FDA product code for PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software is NEZ.

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：NEZ）

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。

K252617MiroCam® 纤维内窥镜系统Intromedic Co., Ltd.K252480CE Deliver (DLV)CapsoVision, Inc.K242643CapsoCam Plus (SV-3) 球囊内镜系统CapsoVision, Inc.K233229NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam TetherAnx Robotica CorporationK230991PillCam SB 3 胶囊内镜系统，PillCam 软件 9.0EGiven Imaging Ltd. (Medtronic)K221590NaviCam Small Bowel Capsule Endoscopy SystemAnkon Technologies Co., Ltd.

官方来源

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