Cleared Traditional

K073543 - OEC 9900 ELITE

K073543 is an FDA 510(k) clearance for OEC 9900 ELITE, manufactured by Ge Oec Medical Systems. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K073543 · Ge Oec Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
137d
Days
Class 2
Risk

K073543 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 Oec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on May 2, 2008 after a review of 137 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K073543

510(k) Number K073543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2007
Decision Date May 02, 2008
Days to Decision 137 days
Submission Type Traditional
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
30d slower than avg
Panel avg: 107d · This submission: 137d
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 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K073543.
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K070834 · Omega Medical Imaging, Inc. · May 2007
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K070123 · Dornier Medtech America, Inc. · Mar 2007
K073543 · OEC 9900 ELITE
Download PDF FDA Summary Ge Oec Medical Systems