Cleared Special

K091658 - GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 (FDA 510(k) Clearance)

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

K091658 · Ge Healthcare · Radiology device
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Jun 2009
Decision
20d
Days
Class 2
Risk

K091658 is an FDA 510(k) clearance for the GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 41.... Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ge Healthcare (Waukesha, US). The FDA issued a Cleared decision on June 29, 2009 after a review of 20 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.

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Submission Details

510(k) Number K091658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date June 29, 2009
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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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