Cleared Special

K122234 - OEC 9900 ELITE

K122234 is an FDA 510(k) clearance for OEC 9900 ELITE, manufactured by Ge Healthcare Surgery GE Oec Medical Systems, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 21-day FDA review.

K122234 · Ge Healthcare Surgery GE Oec Medical Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
21d
Days
Class 2
Risk

K122234 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 GE Oec Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on August 16, 2012 after a review of 21 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 Ge Healthcare Surgery GE Oec Medical Systems, Inc. devices

FDA 510(k) Submission Details - K122234

510(k) Number K122234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2012
Decision Date August 16, 2012
Days to Decision 21 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
86d faster than avg
Panel avg: 107d · This submission: 21d
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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 246
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