Cleared Traditional

K023178 - INNOVA 4100

K023178 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 64-day FDA review.

K023178 · Ge Medical Systems, Inc. · Radiology device
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Nov 2002
Decision
64d
Days
Class 2
Risk

K023178 is an FDA 510(k) clearance for the INNOVA 4100. 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 November 26, 2002 after a review of 64 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 - K023178

510(k) Number K023178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date November 26, 2002
Days to Decision 64 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
43d faster than avg
Panel avg: 107d · This submission: 64d
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 K023178.
INNOVA 3100
K031637 · GE Medical Systems · Aug 2003
PHILLIPS OMNIDIAGNOST ELEVA
K032046 · Philips Medical Systems, Inc. · Jul 2003
INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)
K024200 · Ge Medical Systems, Inc. · Jan 2003
INNOVA AND INNOVA 2000 S
K022322 · Ge Medical Systems, Inc. · Oct 2002
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D
K013608 · Toshiba America Medical Systems, In.C · Nov 2001
U04
K010942 · Siemens Medical Solutions USA, Inc. · Apr 2001