Televere 数字牙科成像系统
K号: K181358 · 2018-06-20
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决定日期2018-06-20
产品代码MUH
咨询委员会DE
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器械摘要
Televere Digital Dental Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Televere Systems, Inc.. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K181358. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Televere Digital Dental Imaging System?
Televere Digital Dental Imaging System is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Televere Systems, Inc.. The 510(k) number is K181358.
When did Televere Digital Dental Imaging System receive FDA 510(k) clearance?
Televere Digital Dental Imaging System received FDA 510(k) clearance on 2018-06-20, under 510(k) number K181358.
Who is the listed applicant for Televere Digital Dental Imaging System?
The FDA 510(k) record lists Televere Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Televere Digital Dental Imaging System?
The FDA product code for Televere Digital Dental Imaging System is MUH.
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Televere Systems, Inc.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：MUH）
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。
K251793SOTA Cloud Smart Sensor (1.5)Sota Cloud Corp.K252570EzSensor HD, EzSensor UHDQpix Solutions, Inc.K250687茧状单机（DX-7020s）Dexcowin Global, Inc.K251206Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc.K240040VistaPano S Ceph 2.0（VistaPano S Ceph）；VistaPano S 2.0（VistaPano S）；ProVecta S-Pan Ceph 2.0（ProVecta S-Pan Ceph）；ProVecta S-Pan 2.0（ProVecta S-Pan）VATECH Co., Ltd.K242778X传感器（型号：IOS-A15IF，HDI-15DGF）Qpix Solutions, 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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