Cleared Traditional

K021049 - OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM

K021049 is an FDA 510(k) clearance for OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM, 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 16-day FDA review.

K021049 · Ge Oec Medical Systems · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
16d
Days
Class 2
Risk

K021049 is an FDA 510(k) clearance for the OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM. 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 April 17, 2002 after a review of 16 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021049

510(k) Number K021049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2002
Decision Date April 17, 2002
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
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 K021049.
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc. · Oct 2002
OEC FLUOROTRAK 9800 PLUS
K022069 · Ge Oec Medical Systems · Sep 2002
IMPERIUM
K022114 · Elmstech, Inc. · Sep 2002
ORION DIGITAL IMAGING SYSTEM
K012490 · Infimed, Inc. · Feb 2002
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · Toshiba America Medical Systems, In.C · Nov 2001
UROLOGIC
K011311 · Pck Electronic Industry and Trade Co, Ltd. · Jul 2001
K021049 · OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
Download PDF FDA Summary Ge Oec Medical Systems