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FDA 510(k)

Trident HD Specimen Radiography System

K-Number: K182727 · 2019-01-10

ApplicantHologic, Inc.
Decision Date2019-01-10
Product CodeMWP
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Trident HD Specimen Radiography System is a medical device manufactured by Hologic, Inc.. It received FDA 510(k) clearance on 2019-01-10 under approval number K182727. The device is classified under product code MWP. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trident HD Specimen Radiography System?

Trident HD Specimen Radiography System is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Hologic, Inc.. The 510(k) number is K182727.

When was Trident HD Specimen Radiography System approved by the FDA?

Trident HD Specimen Radiography System received FDA 510(k) clearance on 2019-01-10, under approval number K182727.

What company makes Trident HD Specimen Radiography System?

Trident HD Specimen Radiography System is manufactured by Hologic, Inc..

What is the FDA product code for Trident HD Specimen Radiography System?

The FDA product code for Trident HD Specimen Radiography System is MWP.

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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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