用于乳腺癌检测的荧光成像
PMA编号：P230014 · 2025-11-25
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决定日期2025-11-25
PMA 编号P230014
产品代码SAW
设备分类第3类
医疗专科U
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
器械摘要
Fluorescence imaging for breast cancer detection is the device name listed in this FDA 510(k) record. The listed applicant is Lumicell, Inc.. It received FDA 510(k) clearance on 2025-11-25. The device is classified under product code SAW. It was reviewed by the SU advisory panel.
常见问题
What is the Fluorescence imaging for breast cancer detection?
Fluorescence imaging for breast cancer detection is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Lumicell, Inc..
When did Fluorescence imaging for breast cancer detection receive FDA 510(k) clearance?
The clearance date for Fluorescence imaging for breast cancer detection can be found in the official FDA records.
Who is the listed applicant for Fluorescence imaging for breast cancer detection?
The FDA 510(k) record lists Lumicell, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fluorescence imaging for breast cancer detection?
The FDA product code for Fluorescence imaging for breast cancer detection is SAW.
相关临床试验
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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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