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FDA PMA

Digital breast tomosynthesis

PMA Number: P080003 · 2025-11-24

ApplicantHologic, Inc.
Decision Date2025-11-24
PMA NumberP080003
Product CodeOTE
Device ClassClass 3
Medical SpecialtyU
Advisory CommitteeRA

Device Summary

Digital breast tomosynthesis is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2025-11-24. The device is classified under product code OTE. It was reviewed by the RA advisory panel.

Frequently Asked Questions

What is the Digital breast tomosynthesis?

Digital breast tomosynthesis is a medical device that received FDA 510(k) clearance on 2025-11-24. The listed applicant is Hologic, Inc..

When did Digital breast tomosynthesis receive FDA 510(k) clearance?

The clearance date for Digital breast tomosynthesis can be found in the official FDA records.

Who is the listed applicant for Digital breast tomosynthesis?

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 Digital breast tomosynthesis?

The FDA product code for Digital breast tomosynthesis is OTE.

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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