Cleared Abbreviated

K052039 - GE OEC ALTITUDE

K052039 is an FDA 510(k) clearance for GE OEC ALTITUDE, manufactured by Ge Oec Medical Systems. The device is a Class 2 Radiology device with product code IZI cleared through the Abbreviated 510(k) pathway after a 14-day FDA review.

K052039 · Ge Oec Medical Systems · Radiology device
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Aug 2005
Decision
14d
Days
Class 2
Risk

K052039 is an FDA 510(k) clearance for the GE OEC ALTITUDE. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Ge Oec Medical Systems (Salt Lake City, US). The FDA issued a Cleared decision on August 11, 2005 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - the FDA radiology and imaging software oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Ge Oec Medical Systems devices

FDA 510(k) Submission Details - K052039

510(k) Number K052039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2005
Decision Date August 11, 2005
Days to Decision 14 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Standards-based clearance path.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 141
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K052039.
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