Cleared Special

K042605 - COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY

K042605 is an FDA 510(k) clearance for COLONGRAPHY SOFTWARE PACKAGE WITH EXTEN..., manufactured by Siemens AG Medical Solutions. The device is a Class 2 Radiology device with product code NWE cleared through the Special 510(k) pathway after a 14-day FDA review.

K042605 · Siemens AG Medical Solutions · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K042605

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
Combination Product No
PCCP Authorized No
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.

NWE Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

K042605 · COLONGRAPHY SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
Download PDF FDA Summary Siemens AG Medical So…