PROBEAT-FR
K号: K232032 · 2024-01-12
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器械摘要
PROBEAT-FR is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. It received FDA 510(k) clearance on 2024-01-12 under 510(k) number K232032. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PROBEAT-FR?
PROBEAT-FR is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. The 510(k) number is K232032.
When did PROBEAT-FR receive FDA 510(k) clearance?
PROBEAT-FR received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232032.
Who is the listed applicant for PROBEAT-FR?
The FDA 510(k) record lists Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PROBEAT-FR?
The FDA product code for PROBEAT-FR is LHN.
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Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha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：LHN）
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。
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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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