CRUXVIEW
K号: K211317 · 2021-07-29
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决定日期2021-07-29
产品代码MUH
咨询委员会DE
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器械摘要
CRUXVIEW is the device name listed in this FDA 510(k) record. The listed applicant is Cruxell Corp.. It received FDA 510(k) clearance on 2021-07-29 under 510(k) number K211317. 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 CRUXVIEW?
CRUXVIEW is a medical device that received FDA 510(k) clearance on 2021-07-29. The listed applicant is Cruxell Corp.. The 510(k) number is K211317.
When did CRUXVIEW receive FDA 510(k) clearance?
CRUXVIEW received FDA 510(k) clearance on 2021-07-29, under 510(k) number K211317.
Who is the listed applicant for CRUXVIEW?
The FDA 510(k) record lists Cruxell Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CRUXVIEW?
The FDA product code for CRUXVIEW 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Cruxell Corp.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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