Cleared Traditional

VIDAR BONE TRACK SYSTEM SOFTWARE (K024171) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K024171 · Vidar Systems Corp. · Radiology device
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Mar 2003
Decision
76d
Days
Class 2
Risk

K024171 is an FDA 510(k) clearance for the VIDAR BONE TRACK SYSTEM SOFTWARE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Vidar Systems Corp. (Ashland, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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 Vidar Systems Corp. devices

Submission Details

510(k) Number K024171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2002
Decision Date March 04, 2003
Days to Decision 76 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 107d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 352
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K024171.
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LUNG NODULE ASSESSMENT AND COMPARISON OPTION
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LUNGCARE CT SOFTWARE PACKAGE
K022013 · Siemens Medical Solutions USA, Inc. · Jul 2002
ADVANCED LUNG ANALYSIS-1
K013381 · General Electric Co. · Oct 2001