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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 the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) 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. The listed applicant is Hologic, Inc.. The 510(k) number is K182727.

When did Trident HD Specimen Radiography System receive FDA 510(k) clearance?

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

Who is the listed applicant for Trident HD Specimen Radiography System?

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 Trident HD Specimen Radiography System?

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

Related Clinical Trials

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Related Devices (Code: MWP)

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.

K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,LtdK230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,LtdK213691Solas ORCirdan Imaging, Ltd.K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc.K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc.K210956Kubtec Mozart (XPERT42)Kub Technologies, Inc.

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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