Cleared Traditional

K140920 - SYNGO.CT COLONOGRAPHY

K140920 is an FDA 510(k) clearance for SYNGO.CT COLONOGRAPHY, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code NWE cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K140920 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 2014
Decision
237d
Days
Class 2
Risk

K140920 is an FDA 510(k) clearance for the SYNGO.CT COLONOGRAPHY. Classified as Colon Computed Tomography System, Computer Aided Detection (product code NWE), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on December 3, 2014 after a review of 237 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K140920

510(k) Number K140920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2014
Decision Date December 03, 2014
Days to Decision 237 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 107d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.