Cleared Traditional

K061163 - INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT

K061163 is an FDA 510(k) clearance for INNOVA 2121IQ, manufactured by Ge Medical Systems, LLC. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K061163 · Ge Medical Systems, LLC · Radiology device
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Jun 2006
Decision
42d
Days
Class 2
Risk

K061163 is an FDA 510(k) clearance for the INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA.... Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on June 7, 2006 after a review of 42 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.

View all Ge Medical Systems, LLC devices

FDA 510(k) Submission Details - K061163

510(k) Number K061163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2006
Decision Date June 07, 2006
Days to Decision 42 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
65d faster than avg
Panel avg: 107d · This submission: 42d
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 302
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K061163.
ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
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ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM
K061203 · Ziehm Imaging, Inc. · Jun 2006
CPIVISION DIGITAL IMAGING SYSTEM
K061173 · Communications & Power Industries Canada, Inc. · Jun 2006
AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM
K052202 · Siemens Medical Solutions USA, Inc. · Mar 2006
DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121
K060259 · Ge Medical Systems, LLC · Feb 2006
UROVANTAGE
K053279 · Pck Electronic Industry & Trade Co., Ltd. · Dec 2005