Dendrite成像系统
K号: K253303 · 2025-11-28
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决定日期2025-11-28
产品代码QDG
咨询委员会SU
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决定实质等同
器械摘要
Dendrite Imaging System is the device name listed in this FDA 510(k) record. The listed applicant is Dendrite Imaging, Inc.. It received FDA 510(k) clearance on 2025-11-28 under 510(k) number K253303. The device is classified under product code QDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Dendrite Imaging System?
Dendrite Imaging System is a medical device that received FDA 510(k) clearance on 2025-11-28. The listed applicant is Dendrite Imaging, Inc.. The 510(k) number is K253303.
When did Dendrite Imaging System receive FDA 510(k) clearance?
Dendrite Imaging System received FDA 510(k) clearance on 2025-11-28, under 510(k) number K253303.
Who is the listed applicant for Dendrite Imaging System?
The FDA 510(k) record lists Dendrite Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Dendrite Imaging System?
The FDA product code for Dendrite Imaging System is QDG.
相关临床试验
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相关器械（代码：QDG）
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。
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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