Cleared Traditional

K083423 - COLONCAD API 3.1 (FDA 510(k) Clearance)

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

K083423 · Medicsight Plc · Radiology device
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May 2011
Decision
909d
Days
Class 2
Risk

K083423 is an FDA 510(k) clearance for the COLONCAD API 3.1. Classified as Colon Computed Tomography System, Computer Aided Detection (product code NWE), Class II - Special Controls.

Submitted by Medicsight Plc (London, GB). The FDA issued a Cleared decision on May 17, 2011 after a review of 909 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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.

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Submission Details

510(k) Number K083423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2008
Decision Date May 17, 2011
Days to Decision 909 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
802d slower than avg
Panel avg: 107d · This submission: 909d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NWE Colon Computed Tomography System, Computer Aided Detection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Assist Radiologists In The Review Of Multi-slice Computed Tomography (msct) Exams Of The Colon And Highlight Potential Polyps That The Radiologist Should Review.
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.