Cleared Traditional

K091529 - ICAD VERALOOK CTC CAD SOFTWARE

K091529 is an FDA 510(k) clearance for ICAD VERALOOK CTC CAD SOFTWARE, manufactured by Icad, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K091529 · Icad, Inc. · Radiology device
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Aug 2010
Decision
439d
Days
Class 2
Risk

K091529 is an FDA 510(k) clearance for the ICAD VERALOOK CTC CAD SOFTWARE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Icad, Inc. (Nashua, US). The FDA issued a Cleared decision on August 4, 2010 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all Icad, Inc. devices

FDA 510(k) Submission Details - K091529

510(k) Number K091529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2009
Decision Date August 04, 2010
Days to Decision 439 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
332d slower than avg
Panel avg: 107d · This submission: 439d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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.

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All 636
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