Cleared Special

K042605 - COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY (FDA 510(k) Clearance)

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K042605 · Siemens AG Medical Solutions · Radiology device
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Oct 2004
Decision
14d
Days
Class 2
Risk

K042605 is an FDA 510(k) clearance for the COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY. Classified as Colon Computed Tomography System, Computer Aided Detection (product code NWE), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Erlangen, DE). The FDA issued a Cleared decision on October 8, 2004 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K042605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2004
Decision Date October 08, 2004
Days to Decision 14 days
Submission Type Special
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
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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.