Cleared Traditional

K033244 - DIGITAL FLUOROSCOPIC IMAGING SYSTEM

K033244 is an FDA 510(k) clearance for DIGITAL FLUOROSCOPIC IMAGING SYSTEM, 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 9-day FDA review.

K033244 · Ge Medical Systems, Inc. · Radiology device
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Oct 2003
Decision
9d
Days
Class 2
Risk

K033244 is an FDA 510(k) clearance for the DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION. 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 October 16, 2003 after a review of 9 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 - K033244

510(k) Number K033244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2003
Decision Date October 16, 2003
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Intertek Testing Services
DONALD JAMES SHERRATT

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K033244.
INNOVA 4100, INNOVA 3100
K042053 · Ge Medical Systems, Inc. · Aug 2004
AXIOM ARTIS U
K040675 · Siemens Medical Systems, Inc. · Jun 2004
ALLURA XPER FD20
K033737 · Philips Medical Systems North America, Inc. · Dec 2003
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