Cleared Special

SOMATOM EMOTION 6 CT SYSTEMS (K023687) - FDA 510(k) Clearance

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

K023687 · Siemens Medical Systems, Inc. · Radiology device
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Nov 2002
Decision
21d
Days
Class 2
Risk

K023687 is an FDA 510(k) clearance for the SOMATOM EMOTION 6 CT SYSTEMS. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Iselin, US). The FDA issued a Cleared decision on November 22, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - 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.

View all Siemens Medical Systems, Inc. devices

Submission Details

510(k) Number K023687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2002
Decision Date November 22, 2002
Days to Decision 21 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 107d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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.

Regulatory Peers - JAK System, X-ray, Tomography, Computed

All 352
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K023687.
SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION
K032475 · Siemens Medical Solutions USA, Inc. · Nov 2003
SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION
K032536 · Siemens Medical Solutions USA, Inc. · Nov 2003
LUNG NODULE ASSESSMENT AND COMPARISON OPTION
K023785 · Philips Medical Systems (Cleveland), Inc. · Feb 2003
LUNGCARE CT SOFTWARE PACKAGE
K022013 · Siemens Medical Solutions USA, Inc. · Jul 2002
ADVANCED LUNG ANALYSIS-1
K013381 · General Electric Co. · Oct 2001
IN SPACE 3D
K011447 · Siemens Medical Solutions USA, Inc. · Aug 2001