Cleared Traditional

K123901 - TRACTUS TISSUEMAPPER REVIEWER APPLICATION

K123901 is an FDA 510(k) clearance for TRACTUS TISSUEMAPPER REVIEWER APPLICATION, manufactured by Tractus Corporation. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K123901 · Tractus Corporation · Radiology device
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Jan 2013
Decision
42d
Days
Class 2
Risk

K123901 is an FDA 510(k) clearance for the TRACTUS TISSUEMAPPER REVIEWER APPLICATION. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Tractus Corporation (Danville, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Tractus Corporation devices

FDA 510(k) Submission Details - K123901

510(k) Number K123901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2012
Decision Date January 29, 2013
Days to Decision 42 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
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 - LLZ System, Image Processing, Radiological

All 1267
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K123901.
CORONIS FUSION 6MP
K130103 · Barco N.V. · Feb 2013
CAAS INTRAVASCULAR
K123970 · Pie Medical Imaging BV · Feb 2013
SYNGO, BREAST CARE
K123420 · Siemens Medical Solutions USA, Inc. · Feb 2013
SYNAPSE 3D COLON ANALYSIS
K123566 · Fujifilm Medical Systems U.S.A, Inc. · Jan 2013
SYNGO.VIA MI WORKFLOWS
K123577 · Siemens Medical Solutions USA, Inc. · Jan 2013
CARDIAC VX
K121762 · Ge Medical Systems, LLC · Jan 2013