Cleared Traditional

K082781 - OEC 9900 ELITE

K082781 is an FDA 510(k) clearance for OEC 9900 ELITE, manufactured by Ge Healthcare Surgery. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 221-day FDA review.

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

FDA 510(k) Submission Details - K082781

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.

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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 246
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K082781.
ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO
K091918 · Genoray Co., Ltd. · Oct 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ
K092004 · Ge Healthcare · Aug 2009
GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121
K091658 · Ge Healthcare · Jun 2009
VERADIUS, MODEL 718-130
K090590 · Philips Medical Systems North America Co. · Mar 2009
AXIOM LUMINOS DRF
K062623 · Siemens Medical Solutions USA, Inc. · Aug 2007
TCA 5R / 5S
K070123 · Dornier Medtech America, Inc. · Mar 2007