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FDA PMA

Analyzer, medical image

PMA Number: P970058 · 2016-04-26

ApplicantHologic, Inc.
Decision Date2016-04-26
PMA NumberP970058
Product CodeMYN
Device ClassClass 2
Medical SpecialtyR
Regulation Number21 CFR 8
Advisory CommitteeRA

Device Summary

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.

Frequently Asked Questions

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?

The FDA 510(k) record lists Hologic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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