Cleared Traditional

K042053 - INNOVA 4100

K042053 is an FDA 510(k) clearance for INNOVA 4100, manufactured by Ge Medical Systems, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K042053 · Ge Medical Systems, Inc. · Radiology device
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Aug 2004
Decision
27d
Days
Class 2
Risk

K042053 is an FDA 510(k) clearance for the INNOVA 4100, INNOVA 3100. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ge Medical Systems, Inc. (Waukesha, US). The FDA issued a Cleared decision on August 26, 2004 after a review of 27 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, Inc. devices

FDA 510(k) Submission Details - K042053

510(k) Number K042053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2004
Decision Date August 26, 2004
Days to Decision 27 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
80d faster than avg
Panel avg: 107d · This submission: 27d
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 245
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K042053.
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · Ge Healthcare · Sep 2005
INNOVA 2100
K050489 · Ge Medical Systems, LLC · Mar 2005
ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)
K042793 · Siemens Medi Cal Solutions, Inc. · Oct 2004
AXIOM ARTIS U
K040675 · Siemens Medical Systems, Inc. · Jun 2004
ALLURA XPER FD20
K033737 · Philips Medical Systems North America, Inc. · Dec 2003
DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION
K033244 · Ge Medical Systems, Inc. · Oct 2003