Hyperion X5，NewTom GO，X-RADiUS COMPACT
K号: K200688 · 2020-04-09
广告
器械摘要
hyperion X5, NewTom GO, X-RADiUS COMPACT is the device name listed in this FDA 510(k) record. The listed applicant is Cefla S.C.. It received FDA 510(k) clearance on 2020-04-09 under 510(k) number K200688. 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 hyperion X5, NewTom GO, X-RADiUS COMPACT?
hyperion X5, NewTom GO, X-RADiUS COMPACT is a medical device that received FDA 510(k) clearance on 2020-04-09. The listed applicant is Cefla S.C.. The 510(k) number is K200688.
When did hyperion X5, NewTom GO, X-RADiUS COMPACT receive FDA 510(k) clearance?
hyperion X5, NewTom GO, X-RADiUS COMPACT received FDA 510(k) clearance on 2020-04-09, under 510(k) number K200688.
Who is the listed applicant for hyperion X5, NewTom GO, X-RADiUS COMPACT?
The FDA 510(k) record lists Cefla S.C. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for hyperion X5, NewTom GO, X-RADiUS COMPACT?
The FDA product code for hyperion X5, NewTom GO, X-RADiUS COMPACT 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Cefla S.C.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。
广告