Cleared Special

SOMATOM DEFINITION (K122471) - FDA 510(k) Clearance

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

K122471 · Siemens Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
28d
Days
Class 2
Risk

K122471 is an FDA 510(k) clearance for the SOMATOM DEFINITION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Systems, Inc. (Mavern, US). The FDA issued a Cleared decision on September 11, 2012 after a review of 28 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 K122471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date September 11, 2012
Days to Decision 28 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
79d faster than avg
Panel avg: 107d · This submission: 28d
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 K122471.
SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16
K133424 · Siemens Medical Solutions USA, Inc. · Jan 2014
SYNGO, CT BONE READING
K123584 · Siemens Medical Solutions USA, Inc. · Mar 2013
SYNGO, CT CARDIAC FUNCTION
K123585 · Siemens Medical Solutions USA, Inc. · Dec 2012
SOMATOM PERSPECTIVE
K113287 · Siemens Medical Solutions USA, Inc. · May 2012
SAFIRE
K103424 · Siemens Medical Solutions USA, Inc. · Nov 2011
GE VEO RECONSTRUCTION OPTION
K103489 · General Electric Co. · Sep 2011