Cleared Special

SOMATOM DEFINITION FLASH (K121072) - FDA 510(k) Clearance

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

K121072 · Siemens Medical Systems, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
May 2012
Decision
29d
Days
Class 2
Risk

K121072 is an FDA 510(k) clearance for the SOMATOM DEFINITION FLASH. 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 May 8, 2012 after a review of 29 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 K121072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2012
Decision Date May 08, 2012
Days to Decision 29 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
78d faster than avg
Panel avg: 107d · This submission: 29d
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 K121072.
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K123584 · Siemens Medical Solutions USA, Inc. · Mar 2013
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K123585 · Siemens Medical Solutions USA, Inc. · Dec 2012
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K113287 · Siemens Medical Solutions USA, Inc. · May 2012
SAFIRE
K103424 · Siemens Medical Solutions USA, Inc. · Nov 2011
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K103127 · Siemens Medical Solutions USA, Inc. · Mar 2011