Cleared Traditional

OEC 9900 ELITE (K082781) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K082781 · Ge Healthcare Surgery · Radiology device
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May 2009
Decision
221d
Days
Class 2
Risk

K082781 is an FDA 510(k) clearance for the OEC 9900 ELITE. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ge Healthcare Surgery (Salt Lake City, US). The FDA issued a Cleared decision on May 1, 2009 after a review of 221 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ge Healthcare Surgery devices

Submission Details

510(k) Number K082781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2008
Decision Date May 01, 2009
Days to Decision 221 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 107d · This submission: 221d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 183
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