牙科CBCT X射线系统
K号: K251642 · 2025-06-27
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器械摘要
Dental CBCT X-ray System is the device name listed in this FDA 510(k) record. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. It received FDA 510(k) clearance on 2025-06-27 under 510(k) number K251642. 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 CBCT X-ray System?
Dental CBCT X-ray System is a medical device that received FDA 510(k) clearance on 2025-06-27. The listed applicant is Yian Medical Technology (Haining) Co., Ltd.. The 510(k) number is K251642.
When did Dental CBCT X-ray System receive FDA 510(k) clearance?
Dental CBCT X-ray System received FDA 510(k) clearance on 2025-06-27, under 510(k) number K251642.
Who is the listed applicant for Dental CBCT X-ray System?
The FDA 510(k) record lists Yian Medical Technology (Haining) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dental CBCT X-ray System?
The FDA product code for Dental CBCT X-ray System is OAS.
相关临床试验
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列明Yian Medical Technology (Haining) Co., 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。
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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