Cleared Traditional

K182727 - Trident HD Specimen Radiography System

K182727 is an FDA 510(k) clearance for Trident HD Specimen Radiography System, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code MWP cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K182727 · Hologic, Inc. · Radiology device
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Jan 2019
Decision
104d
Days
Class 2
Risk

K182727 is an FDA 510(k) clearance for the Trident HD Specimen Radiography System. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on January 10, 2019 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K182727

510(k) Number K182727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date January 10, 2019
Days to Decision 104 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWP Device Classification - Class 2, Special Controls

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MWP Cabinet, X-ray System

All 22
Devices cleared under the same product code (MWP) and FDA review panel - the closest regulatory comparables to K182727.
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