Cleared Special

K113027 - SYNGO AORTIC VALVEGUIDE SOFTWARE

K113027 is an FDA 510(k) clearance for SYNGO AORTIC VALVEGUIDE SOFTWARE, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 42-day FDA review.

K113027 · Siemens Medical Solutions USA, Inc. · Radiology device
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Nov 2011
Decision
42d
Days
Class 2
Risk

K113027 is an FDA 510(k) clearance for the SYNGO AORTIC VALVEGUIDE SOFTWARE. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Solutions USA, Inc. devices

FDA 510(k) Submission Details - K113027

510(k) Number K113027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2011
Decision Date November 22, 2011
Days to Decision 42 days
Submission Type Special
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
65d faster than avg
Panel avg: 107d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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.

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