OCT 成像系统，配备 AI/ML 软件辅助检测乳腺癌
PMA编号：P250008 · 2026-08-10
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决定日期2026-08-10
PMA 编号P250008
产品代码SHH
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
OCT imaging system with AI/ML software for adjunctive detection of breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2026-08-10. The device is classified under product code SHH. It was reviewed by the SU advisory panel.
常见问题
What is the OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
OCT imaging system with AI/ML software for adjunctive detection of breast cancer is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Perimeter Medical Imaging Ai, Inc..
When did OCT imaging system with AI/ML software for adjunctive detection of breast cancer receive FDA 510(k) clearance?
The clearance date for OCT imaging system with AI/ML software for adjunctive detection of breast cancer can be found in the official FDA records.
Who is the listed applicant for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
The FDA 510(k) record lists Perimeter Medical Imaging Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?
The FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer is SHH.
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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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