OncoStudio (OS-01)
K号: K242994 · 2025-02-24
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器械摘要
OncoStudio (OS-01) is the device name listed in this FDA 510(k) record. The listed applicant is Oncosoft. Co., Ltd.. It received FDA 510(k) clearance on 2025-02-24 under 510(k) number K242994. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OncoStudio (OS-01)?
OncoStudio (OS-01) is a medical device that received FDA 510(k) clearance on 2025-02-24. The listed applicant is Oncosoft. Co., Ltd.. The 510(k) number is K242994.
When did OncoStudio (OS-01) receive FDA 510(k) clearance?
OncoStudio (OS-01) received FDA 510(k) clearance on 2025-02-24, under 510(k) number K242994.
Who is the listed applicant for OncoStudio (OS-01)?
The FDA 510(k) record lists Oncosoft. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OncoStudio (OS-01)?
The FDA product code for OncoStudio (OS-01) is QKB.
相关临床试验
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相关器械（代码：QKB）
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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