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FDA 510(k)

Skan-C 移动 C-臂 X 射线系统 - 230V 变种，Skan-C 移动 C-臂 X 射线系统 - 110V 变种

K号: K170946 · 2017-11-24

申请人Skanray Technologies Private Limited
决定日期2017-11-24
产品代码OXO
咨询委员会RA
决定实质等同

器械摘要

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is the device name listed in this FDA 510(k) record. The listed applicant is Skanray Technologies Private Limited. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K170946. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is Skanray Technologies Private Limited. The 510(k) number is K170946.

When did Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant receive FDA 510(k) clearance?

Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant received FDA 510(k) clearance on 2017-11-24, under 510(k) number K170946.

Who is the listed applicant for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

The FDA 510(k) record lists Skanray Technologies Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant?

The FDA product code for Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant is OXO.

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Skanray Technologies Private Limited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。

K170967Intraskan DC PlusK152831Spot SkanK151512Star 60

相关器械（代码：OXO）

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。

K2532963D数字C-ARMAllengers Medical Systems LimitedK252579Orthoscan TAU MVP Mini C-Arm SystemZiehm-Orthoscan, Inc.K253269OEC One CFDGe Hualun Medical Systems Co. , Ltd.K251004双模式移动C-臂（Geelin500A，Geelin500M）Hefei Chimed Intelligent Machine Co., Ltd.K250587Orthoscan TAU Mini C-ArmZiehm-Orthoscan, Inc.K243452Orthoscan VERSA Mini C-ArmZiehm-Orthoscan, 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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