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FDA PMA

医疗图像分析器

PMA编号:P970058 · 2016-04-26

申请人Hologic, Inc.
决定日期2016-04-26
PMA 编号P970058
产品代码MYN
设备分类第2类
医疗专科R
法规编号21 CFR 8
咨询委员会RA

器械摘要

Analyzer, medical image is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2016-04-26. The device is classified under product code MYN. It was reviewed by the RA advisory panel.

常见问题

What is the Analyzer, medical image?

Analyzer, medical image is a medical device that received FDA 510(k) clearance on 2016-04-26. The listed applicant is Hologic, Inc..

When did Analyzer, medical image receive FDA 510(k) clearance?

The clearance date for Analyzer, medical image can be found in the official FDA records.

Who is the listed applicant for Analyzer, medical image?

FDA 510(k)记录中列出了Hologic, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Analyzer, medical image?

The FDA product code for Analyzer, medical image is MYN.

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