彩虹CT
K号: K200271 · 2021-04-16
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器械摘要
rainbow CT is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K200271. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the rainbow CT?
rainbow CT is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Dentium Co., Ltd (Ict Branch). The 510(k) number is K200271.
When did rainbow CT receive FDA 510(k) clearance?
rainbow CT received FDA 510(k) clearance on 2021-04-16, under 510(k) number K200271.
Who is the listed applicant for rainbow CT?
The FDA 510(k) record lists Dentium Co., Ltd (Ict Branch) as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for rainbow CT?
The FDA product code for rainbow CT is OAS.
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。
列明Dentium Co., Ltd (Ict Branch)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。
相关器械（代码：OAS）
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。
K261748牙科锥形束计算机断层扫描（mDX-15P系列）Hefei Meyer Optoelectronic Technology, Inc.K250839牙科 X-ray 系统Changzhou Boen Zhongding Medical Technology Co., Ltd.K260662牙科锥形束CT系统Yofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.
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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