Cleared Traditional

K110366 - SYNGO.CT CARDIAC FUNCTION

K110366 is an FDA 510(k) clearance for SYNGO.CT CARDIAC FUNCTION, manufactured by Siemens AG. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K110366 · Siemens AG · Radiology device
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Apr 2011
Decision
64d
Days
Class 2
Risk

K110366 is an FDA 510(k) clearance for the SYNGO.CT CARDIAC FUNCTION. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG (Mavern, US). The FDA issued a Cleared decision on April 12, 2011 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens AG devices

FDA 510(k) Submission Details - K110366

510(k) Number K110366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2011
Decision Date April 12, 2011
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

JAK Device Classification - Class 2, Special Controls

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 646
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K110366.
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SOMATOM DEFINITION AS
K103127 · Siemens Medical Solutions USA, Inc. · Mar 2011