Cleared Traditional

K024012 - OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM

K024012 is an FDA 510(k) clearance for OEC 9800 E/CV+ DIGITAL MOBILE IMAGING S..., manufactured by Ge Oec Medical Systems. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K024012 · Ge Oec Medical Systems · Radiology device
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Mar 2003
Decision
106d
Days
Class 2
Risk

K024012 is an FDA 510(k) clearance for the OEC 9800 E/CV+ DIGITAL MOBILE IMAGING SYSTEM. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Ge Oec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on March 20, 2003 after a review of 106 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.

View all Ge Oec Medical Systems devices

FDA 510(k) Submission Details - K024012

510(k) Number K024012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2002
Decision Date March 20, 2003
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 166
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K024012.
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