牙科计算机断层扫描X射线系统
K号: K251842 · 2025-11-13
广告
器械摘要
Dental Computed Tomography X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Fussen Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-11-13 under 510(k) number K251842. 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 Dental Computed Tomography X-ray System?
Dental Computed Tomography X-ray System is a medical device that received FDA 510(k) clearance on 2025-11-13. The listed applicant is Fussen Technology Co., Ltd.. The 510(k) number is K251842.
When did Dental Computed Tomography X-ray System receive FDA 510(k) clearance?
Dental Computed Tomography X-ray System received FDA 510(k) clearance on 2025-11-13, under 510(k) number K251842.
Who is the listed applicant for Dental Computed Tomography X-ray System?
The FDA 510(k) record lists Fussen Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental Computed Tomography X-ray System?
The FDA product code for Dental Computed Tomography X-ray System 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。
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