Cleared Traditional

K111508 - TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001

K111508 is an FDA 510(k) clearance for TRIDENT 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 79-day FDA review.

K111508 · Hologic, Inc. · Radiology device
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Aug 2011
Decision
79d
Days
Class 2
Risk

K111508 is an FDA 510(k) clearance for the TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on August 19, 2011 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K111508

510(k) Number K111508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2011
Decision Date August 19, 2011
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
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 K111508.
Faxitron Bioptics Speciemen Radiography System
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K122428 · Faxitron Bioptics, LLC · Sep 2012
FAXITRON SPECIMEN RADIOGRAPHY SYSTEM, MODEL MX-20
K072557 · Faxitron X-Ray Corp. · Oct 2007
XPERT 40 SPECIMEN RADIOGRAPHY SYSTEM
K071233 · Kub Technologies, Inc. · Jun 2007
FAXITRON DIGITAL RADIOGRAPHY SYSTEM, MODEL DX-50
K061361 · Faxitron X-Ray Corp. · Aug 2006