Tomey 角膜/眼前节光学相干断层扫描仪（CASIA2）
K号: K250553 · 2025-07-18
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决定日期2025-07-18
产品代码OBO
咨询委员会OP
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决定实质等同
器械摘要
Tomey Cornea/Anterior Segment OCT (CASIA2) is the device name listed in this FDA 510(k) record. The listed applicant is Tomey Corporation. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K250553. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Tomey Cornea/Anterior Segment OCT (CASIA2)?
Tomey Cornea/Anterior Segment OCT (CASIA2) is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Tomey Corporation. The 510(k) number is K250553.
When did Tomey Cornea/Anterior Segment OCT (CASIA2) receive FDA 510(k) clearance?
Tomey Cornea/Anterior Segment OCT (CASIA2) received FDA 510(k) clearance on 2025-07-18, under 510(k) number K250553.
Who is the listed applicant for Tomey Cornea/Anterior Segment OCT (CASIA2)?
The FDA 510(k) record lists Tomey Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tomey Cornea/Anterior Segment OCT (CASIA2)?
The FDA product code for Tomey Cornea/Anterior Segment OCT (CASIA2) is OBO.
相关临床试验
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列明Tomey Corporation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：OBO）
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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