Galen™ 第二读™
K号: K241232 · 2025-01-24
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决定日期2025-01-24
产品代码QPN
咨询委员会PA
请注意，由于您没有提供具体的医疗设备监管文本，我无法提供准确的翻译。如果您能提供具体的文本内容，我将能够为您提供准确的翻译。
决定实质等同
器械摘要
Galen™ Second Read™ is the device name listed in this FDA 510(k) record. The listed applicant is Ibex Medical Analytics , Ltd.. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241232. The device is classified under product code QPN. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Galen™ Second Read™?
Galen™ Second Read™ is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Ibex Medical Analytics , Ltd.. The 510(k) number is K241232.
When did Galen™ Second Read™ receive FDA 510(k) clearance?
Galen™ Second Read™ received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241232.
Who is the listed applicant for Galen™ Second Read™?
The FDA 510(k) record lists Ibex Medical Analytics , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Galen™ Second Read™?
The FDA product code for Galen™ Second Read™ is QPN.
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官方来源
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