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FDA 510(k)

无线数字平板探测器型号名称 Mars1417V-TSI，无线数字平板探测器型号名称 Mano4336W

K号: K201004 · 2020-05-01

申请人Iray Technology Taicang , Ltd.
决定日期2020-05-01
产品代码MQB
咨询委员会RA
决定实质等同

器械摘要

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is the device name listed in this FDA 510(k) record. The listed applicant is Iray Technology Taicang , Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K201004. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K201004.

When did Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W receive FDA 510(k) clearance?

Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W received FDA 510(k) clearance on 2020-05-01, under 510(k) number K201004.

Who is the listed applicant for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W?

The FDA product code for Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W is MQB.

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

列明Iray Technology Taicang , Ltd.为申报人的其他记录

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。

K223010便携式X射线系统K222886Mercu 1717VK221714平板探测器K221345无线数字平板探测器K220536数字平板探测器K220668无线数字平板探测器

查看所有 21 个设备 →

相关器械（代码：MQB）

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。

K2538000909FCE，0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996通用 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 探测器 (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211玉山X射线平板探测器Innocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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。

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